Apparatus and Method for Vascular Access

ABSTRACT

In an aspect, embodiments of the invention relate to the effective and accurate placement of intravascular devices such as central venous catheters, in particular such as peripherally inserted central catheters or PICC. One aspect of the present invention relates to vascular access. It describes devices and methods for imaging guided vascular access and more effective sterile packaging and handling of such devices. A second aspect of the present invention relates to the guidance, positioning and placement confirmation of intravascular devices without the help of X-ray imaging. A third aspect of the present invention relates to devices and methods for the skin securement of intravascular devices and post-placement verification of location of such devices. A forth aspect of the present invention relates to improvement of the workflow required for the placement of intravascular devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 60/937,280 filed on Jun. 26, 2007 by Sorin Grunwald etal., entitled “Apparatus and Method for Vascular Access” which isincorporated herein by reference in its entirety.

This application is also a continuation-in-part of U.S. Non-Provisionalpatent application Ser. No. 11/431,140 filed on May 8, 2006 by SorinGrunwald et al., entitled “Endovenous Access and Guidance SystemUtilizing Non-Image Based Ultrasound”, now publication no.2007-0016072-A1; U.S. Non-Provisional patent application Ser. No.11/431,118 filed on May 8, 2006 by Sorin Grunwald et al., entitled“Endovascular Access and Guidance System Utilizing Divergent BeamUltrasound”, now publication no. 2007-0016070-A1; U.S. Non-Provisionalpatent application Ser. No. 11/431,093 filed on May 8, 2006 by SorinGrunwald et al., entitled “Ultrasound Sensor”, now publication no.2007-0016069-A1; and U.S. Non-Provisional patent application Ser. No.11/430,511 filed on May 8, 2006 by Sorin Grunwald et al., entitled“Ultrasound Methods of Positioning Guided Vascular Access Devices in theVenous System”, now publication no. 2007-0016068-A1, all of which claimthe benefit of U.S. Provisional Patent Application No. 60/678,209 filedon May 6, 2005 by Sorin Grunwald et al., entitled “Method and Apparatusfor Intravascular Catheter Guiding and Positioning” and U.S. ProvisionalPatent Application No. 60/682,002 filed on May 18, 2005 by SorinGrunwald et al., entitled “Method and Apparatus for IntravascularCatheter Guiding and Positioning”, each of which is incorporated hereinby reference in their entirety.

All the above-mentioned publications and patent applications arecommonly assigned patent applications (hereinafter referred to as “theVasoNova patent applications”):

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD OF THE INVENTION

The field of the invention relates to guided cannulation of veins andarteries. The field of the invention also relates to the guidance,positioning and placement confirmation of intravascular devices withoutthe help of X-ray imaging. The field of the invention further relates tothe workflow of vascular access procedures, in particular at thebedside.

BACKGROUND

Currently, preparing the patient for and performing vein and arterycannulation is time consuming, challenging in terms of locating theblood vessels and, under circumstances, ensuring the desired vessel isaccessed (e.g., vein vs. artery). Current guided cannulation devices areeither too expensive or difficult to use. General purpose imagingsystems are gaining acceptance but they are expensive and represent anincrease in workflow complexity because they are not sterile. Inaddition, general imaging systems are limited in terms of their abilityto image in near field, i.e., closed to the surface of the skin. Thereis a need for improved placant devices.

Additional challenges remain unaddressed in many areas related toendovascular devices. One challenge that remains is for devices andmethods endovascular positioning within or towards the center of avessel. Another challenge that remains are devices and methods that relyon acoustic triangulation or positioning to localize and placeendovascular devices. Another challenge related to work flow efficiencyand monitoring of the placement and confirmation of endovascular devicelocations. There remains a need in the endovascular field for devices,systems and methods that address these challenges.

In addition RFID (radio frequency identification) tags are currentlybeing used for a number of applications including medical, in particularfor inventory management. The idea of using RFID to optimize processeshas been applied for tracking documents in a workflow.

SUMMARY OF THE INVENTION

In an aspect, embodiments of the invention relate to the effective andaccurate placement of intravascular devices such as central venouscatheters, in particular such as peripherally inserted central cathetersor PICC. One aspect of the present invention relates to vascular access.It describes devices and methods for imaging guided vascular access andmore effective sterile packaging and handling of such devices. A secondaspect of the present invention relates to the guidance, positioning andplacement confirmation of intravascular devices without the help ofX-ray imaging. A third aspect of the present invention relates todevices and methods for the skin securement of intravascular devices andpost-placement verification of location of such devices. A forth aspectof the present invention relates to improvement of the workflow requiredfor the placement of intravascular devices.

Some embodiments of the invention provide devices and methods tosubstantially reduce the amount of time required to place anintravascular device using conventional devices and methods. Someembodiments of the invention provide devices and methods tosubstantially reduce the need for X-ray imaging related to placing suchdevice. Some embodiments of the invention provide devices and methods toincrease placement reliability and accuracy and to verify devicelocation post-placement.

Other aspects of the various embodiments are outlined in the detaileddescription that follows.

An aspect of the invention includes a transcutaneous ultrasound vascularaccess guiding system comprising: a single element ultrasound deviceproviding A-Mode imaging, Doppler and correlation-based blood velocityestimation; a processor to process and correlate ultrasound information;and a system for information output. The transcutaneous ultrasoundvascular access guiding system may also comprise a lens which controlsthe single element ultrasound beam shape. The transcutaneous ultrasoundvascular access guiding system may also comprise a lens which provides amatching layer between the ultrasound transducer and the skin.transcutaneous ultrasound vascular access guiding system comprising canbe constructed as a single-use device. Also, the information can beoutput as a scrolling chart. The Doppler information can bebidirectional. The Doppler acquisition can be pulsed or continuous wave(PW or CW).

Another aspect of the invention includes an endovascular device guideattached to the imaging device capable of guiding several types ofendovascular devices comprising a needle, a stylet, a catheter, and anintroducer. The device may include adaptors to match the outer diameterof the endovascular guided device to the inner diameter of the guide.The device having the ability to slide or otherwise move with respect tothe imaging device as to provide single hand deployment capability ofthe endovascular guided device.

Another aspect of the invention comprises a method of accessing a bloodvessel comprising the steps of: preparing sterile vascular access siteon patient's skin; sliding an access needle or any other type of accessdevice in the device guide, flush align with the tip of the imagingelement, and lock in position; positioning the assembly on the patient'sskin on the sterile site without the use of ultrasound gel; orientingthe assembly like a flashlight until the desired vessel can be seen onthe scrolling chart display; advancing the endovascular element into thevasculature by sliding the guide element over the imaging device; andmonitoring the advancement of the endovascular device towards thedesired target by using at least one element from a list includingA-mode imaging, Doppler flow information, and/or correlation-based bloodflow information.

Another aspect of the invention comprises an endovascular device capableof emitting audible sounds. The sound emitting element or elements maybe placed anywhere along the endovascular member. The sound generatingelements may be actuated by pushing and pulling wires manually. Thesound generating elements may be actuated by motorized movement ofmoving connective parts. The sound generating elements may be actuatedby delivering a gas through a lumen of the endovascular device. Thesound generating elements may be actuated by delivering fluid through alumen of the endovascular device. The sound generating elements may beactuated through interaction with the blood or anatomical sites. Thesound waves may be generated by rubbing together of notched or serratedcomponents. The sound waves may be generated by hitting a stylet againsta solid member in order to generate a repetitive ping. The sound wavesmay be generated by a moving membrane. The sound waves may be generatedby a moving membrane configured to amplify sound. A device lumen isconfigured to amplify sound.

Another aspect of the invention comprises an auscultation systemcomprising one or more sound sensitive elements. The system includes asound processor and an information output device. The severalauscultation devices can be synchronized to provide acoustictriangulation for accurate detection of the endovascular sound source.

Another aspect of the invention includes a guiding method forendovascular devices comprising the steps of: 1) one or more soundsensitive elements are placed on the patient's chest; 2) the soundemitting endovascular device is inserted in the patient's vasculature;3) The endovascular device emits sound continuously, intermittently oron demand; and 4) Sound sensitive elements detect the sound generated bythe endovascular device. The sound intensity can be used to estimate thedistance between the sound emitting element and the sound sensitiveelement. The sound detected by several sound sensitive elements can betriangulate as to find the location of the sound source with respect tothe sound detecting elements.

Another aspect of the invention includes a method to locate anendovascular device comprising an ultrasound sensor using one or severaltranscutaneous ultrasound systems comprising the steps of: 1)introducing an endovascular member containing an ultrasound sensor intothe vasculature of a body; 2) sending and receiving ultrasound waves inthe vasculature using the ultrasound sensor; 3) placing one or moretranscutaneous ultrasound systems on the patient's body; detecting theinterference between the endovascular ultrasound device and thetranscutaneous ultrasound systems with either the endovascular sensor orwith either of transcutaneous systems; notifying the user wheninterference has been detected such the user becomes aware of thepresence of the endovascular device in the field of view of thetranscutaneous systems. The endovascular device is able to emitultrasound signals. The endovascular device is able to receiveultrasound signals. The transcutaneous ultrasound system is able to emitultrasound signals. The transcutaneous ultrasound system is able toreceive ultrasound signals transcutaneous ultrasound system. Thetranscutaneous ultrasound system can be an ultrasound imaging scan headconnecting to an ultrasound imaging system. Several transcutaneousultrasound systems can be used to triangulate the location of theendovascular ultrasound sensor. The endovascular ultrasound device isconnected to the one or more transcutaneous system such as to allowsynchronization of transmitting and receiving ultrasound waves in thesame region of the body.

Another aspect of the invention includes an endovascular devicecomprising means to separate its tip from the inner blood vessel wallwhile maintaining the blood stream flow. A distal segment of theendovascular device is flexible and made of metal or polymer, and thepolymer may be reinforced to increase tensile strength. The separationfrom the wall is provided by a star shaped balloon. The separation fromthe wall is provided by a 2 piece displaced asymmetrical shaped balloon.The separation from the wall is provided by a deployable circular braid.The separation from the wall is provided by a deployable balloon. Theseparation from the wall is provided by strips cut in the devicematerial and deployed using a deployment member. The separation from thewall is provided by a deployable basket.

Another aspect of the invention includes an endovascular devicecomprising means to align its tip with the blood stream whilemaintaining the blood stream flow. The means comprises axial alignmentthat is facilitated by a tether component. The alignment with the bloodstream is provided by a star shaped balloon. The alignment with theblood stream is provided by a 2 piece displaced asymmetrical shapedballoon. The alignment with the blood stream is provided by a deployablecircular braid. The alignment with the blood stream is provided by adeployable balloon. The alignment with the blood stream is provided bystrips cut in the device material and deployed using a deploymentmember. The alignment with the blood stream is provided by a deployablebasket.

Another aspect of the invention includes a securement device for anendovascular member which provides electrical and optical sensorconnectors and actuation elements to connect and control sensors anddevices attached at the distal end of the endovascular members.

Another aspect of the invention includes a system for tracking clinicalprocedures and improve workflow efficiency comprising: a workflowprocessor; an input interface; an output interface; a code reader; acommunication component; and a database interface. The workflowprocessor stores information about procedure times, device information,patient and operator information, calculates parameters of the procedurelike time duration and elapsed time between activities, and providesstatistical data analysis of such parameters. The information about theendovascular procedure can be input into the system through a dedicateduser interface guiding data acquisition. The output interface presentsresults of procedure workflow analysis. The code reader can be an RFIDreader, a bar code reader or a reader of any computer readable label.The communication component can communicate over the network (wired orwireless) with the hospital information system. The communicationcomponent can communicate with other systems for tracking clinicalprocedures and establish a network of such systems. The databaseinterface allows the procedure and workflow information to be archived.

Another aspect of the invention includes a method for tracking clinicalprocedures and improve workflow efficiency comprising the steps of: 1)Input to the time when a consult request has been received; 2) Input thetime when a work step is started; and 3) Input the time when a work stepis finished. The a work step comprises the following activities:

a. Gather patient data (check history, allergies, lab results, etc)

b. Transportation to case (cart/supplies)

c. Obtain patient consent

d. Gain vascular access, e.g., venipuncture

e. Place endovascular device or any other type of device

f. Provide therapy through the endovascular device

g. Remove or secure the endovascular device

h. Order/wait for x-ray or other confirmatory imaging modality

i. Reposition device in case x-ray does not confirm location; and

j. Document that endovascular device is ready for use\

In one aspect of the invention, there is a transcutaneous ultrasoundvascular access guiding system having one or more of: an elongate bodyhaving a handle; a guide on the elongate body configured to receive avascular access device; a single element ultrasound device on theelongate body configured to provide A-Mode imaging, Doppler andcorrelation-based blood velocity estimation; a processor to process andcorrelate ultrasound information from the single element ultrasounddevice; and a system for information output based on the output of theprocessor.

The guiding system may also include a lens positioned to control thesingle element ultrasound beam shape or a lens positioned on theultrasound device configured to provide a matching layer between theultrasound transducer and the skin.

Numerous alternatives are possible such as being constructed as asingle-use device or where the information output is a scrolling chart.Additionally, the Doppler information can be bidirectional and/or theDoppler acquisition can be pulsed wave or continuous wave. Additionally,the guide attached to the imaging device is configured to guide one ofthe endovascular device selected from the group consisting of: a needle;a stylet; a catheter; and an introducer. There may also be an adaptor tomatch the outer diameter of the endovascular guided device to the innerdiameter of the guide. The endovascular device may also be configured toslide or move with respect to the imaging device as to provide singlehand deployment capability of the endovascular guided devices describedherein.

In another aspect, there is a method of accessing a blood vesselcomprising one or more of the steps of: preparing sterile vascularaccess site on patient's skin; sliding a vascular access device in thedevice guide, flush aligning with the tip of the imaging element, andlocking in position; positioning the assembly on the patient's skin onthe sterile site without the use of ultrasound gel; orienting theassembly like a flashlight until the desired vessel can be seen on thescrolling chart display; advancing the endovascular element into thevasculature by sliding the guide element over the imaging device; andmonitoring the advancement of the endovascular device towards thedesired target by using at least one element from a list including:A-mode imaging, Doppler flow information, and correlation-based bloodflow information.

In another aspect, there is an endovascular device having an elongatebody; an element on or in the elongate body configured to generate, emitor produce sound waves; and a device to control the generation, emissionor production of sound waves from the element. The element may be placedon or in the elongate body. In one aspect, the device to control mayoperate by pushing and pulling wires manually. In another aspect, thedevice to control may be actuated by motorized movement of movingconnective parts. The device to control generation of the element may beactuated by delivering a gas through a lumen on or in the elongate body.The sound generating elements may be actuated by delivering fluidthrough a lumen of the endovascular device. The sound generatingelements may be actuated through interaction with the blood or ananatomical site. The sound waves may be generated by rubbing notched orserrated components. The sound waves may be generated by hitting astylet against a solid member in order to generate a repetitive ping.The sound waves may be generated by a moving membrane. The sound wavesmay be generated by a moving membrane configured to amplify sound. Theremay also be a device lumen is configured to amplify sound.

In another aspect, there is an auscultation system having one or moreof: one or more sound sensitive elements; a sound processor incommunication with the one or more sound sensitive elements; and aninformation output device in communication with the sound processor. Inone aspect, the sound processor is configured such that a plurality ofauscultation devices can be synchronized to provide acoustictriangulation for accurate detection of an endovascular sound source.

In another aspect, there is a guiding method for endovascular devicesperformed by one or more of the steps of: positioning one or more soundsensitive elements on a patient's chest; inserting a sound emittingendovascular device into the patient's vasculature; emitting, producingor generating sound or pressure waves from the endovascular device; anddetecting the sound or pressure waves from the emitting step with thesound sensitive elements. In one aspect, the emitting step is performedcontinuously, intermittently or on demand. In another aspect, the soundintensity measured in the detecting step is used to estimate thedistance between the sound emitting endovascular device and the one ormore sound sensitive elements. The method may also include the step oftriangulating the sounds from the detecting step to locate the soundemitting endovascular device with respect to the one or more soundsensitive elements.

In still another aspect, there is a method to locate an endovasculardevice comprising an ultrasound sensor using one or more transcutaneousultrasound systems by performing the steps of: introducing anendovascular member containing an ultrasound sensor into the vasculatureof a body; sending and receiving ultrasound waves in the vasculatureusing the ultrasound sensor; placing one or more transcutaneousultrasound systems on the patient's body; detecting the interferencebetween the endovascular ultrasound device and the transcutaneousultrasound systems using either the endovascular sensor or with any ofthe transcutaneous systems; and notifying the user when interference hasbeen detected such the user becomes aware of the presence of theendovascular device in the field of view of the transcutaneous systems.In one alternative, the endovascular device is configured to emit orreceive ultrasound signals. In one alternative, the transcutaneousultrasound system is configured to emit or receive ultrasound signals.In another aspect, the transcutaneous ultrasound system is configured asan ultrasound imaging scan head connecting to an ultrasound imagingsystem. The information in the detecting step from severaltranscutaneous ultrasound systems is used for triangulating and/orlocating the endovascular ultrasound sensor. In another alternative, theendovascular ultrasound device is connected to the one or moretranscutaneous system such as to allow synchronization of transmittingand receiving ultrasound waves in the same region of the body.

In another alternative embodiment, there is an endovascular device withan elongate body sized for insertion into the vasculature; a sensor onthe distal end of the elongate body; and a structure on or in theelongate body to move its tip from an inner blood vessel wall whilemaintaining the blood stream flow when the endovascular device is in ablood vessel. The elongate body may also include a distal segment thatis flexible and made of metal or polymer, and the polymer may bereinforced to increase tensile strength. The structure is a star shapedballoon on or about the elongate body; or a 2 piece displacedasymmetrical shaped balloon; or a deployable circular braid; ordeployable balloon; or a deployable basket. In one aspect, the structurealso includes strips cut in the elongate body material; and the stripsare adapted to be deployed to move the endovascular device from a wallusing a deployment member.

In still another aspect, there is an endovascular device having anelongate body sized for insertion into the vasculature; a sensor on thedistal end of the elongate body; and a structure configured to align theelongate body tip or the sensor with the blood stream while maintainingthe blood stream flow. The structure may include axial alignment oralignment within the bloodstream facilitated by a tether componentattached to the elongate body; or provided by a star shaped balloon; orprovided by a 2 piece displaced asymmetrical shaped balloon; or providedby a deployable circular braid; or provided by a deployable balloon; orprovided by strips cut in the elongate body material and deployed usinga deployment member; or provided by a deployable basket.

In another alternative embodiment, there is a securement device for anendovascular member that provides electrical and optical sensorconnectors and actuation elements to connect and control sensors anddevices attached at the distal end of the endovascular members.

In another aspect, there is a system for tracking clinical proceduresand workflow having one or more of: a workflow processor; an inputinterface; an output interface; a code reader; a communicationcomponent; and a database interface. The workflow processor may storeinformation about procedure times, device information, patient andoperator information, calculate parameters of the procedure like timeduration and elapsed time between activities, and provide statisticaldata analysis of such parameters. The information about the endovascularprocedure may be input into the system through a dedicated userinterface guiding data acquisition. The output interface may presentresults of procedure workflow analysis. The code reader can be an RFIDreader, a bar code reader or a reader of any computer readable label.The communication component can communicate over a wired network or awireless network with a hospital information system. The communicationcomponent can communicate with other systems for tracking clinicalprocedures and establish a network of such systems. The databaseinterface allows the procedure and workflow information to be archived.

In another aspect, there is a method for tracking clinical proceduresand workflow, having one or more of the steps of: entering a time when aconsult request is received; entering a time when a work step isstarted; and entering a time when a work step is finished. The work stepmay include one or more of the following activities: gathering patientdata; transporting to a case; obtaining patient consent; gainingvascular access; placing an endovascular device or any other type ofdevice; providing therapy through the endovascular device; removing orsecuring an endovascular device; ordering or waiting for x-ray or otherconfirmatory imaging modality; repositioning a device based on inputfrom an imaging modality; and documenting that an endovascular device isready for use.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a disposable or reusable imaging and guiding devicefor vascular access.

FIG. 2 illustrates interaction of solid components rubbing together ofnotched components at the catheter tip with similar notched or serratedcomponents at the distal end of a stylet that passes through one of thecatheter lumens.

FIG. 3 shows an embodiment in which the motion required is perpendicularto the stylet axis.

FIG. 4 shows an embodiment in which the motion required is parallel tothe stylet axis.

FIG. 5 illustrated motion of the valve flap or flaps is induced by therapid injection of a liquid or gas such as CO₂ through the catheterlumen within which valve resides.

FIG. 6 illustrated motion of the valve flap or flaps is induced by therapid injection of a liquid or gas such as CO₂ through the catheterlumen within which valve resides.

FIG. 7 illustrates an embodiment, in which a convoluted lumen acts as anamplifier, thus enabling a smaller sized membrane that can be positionedin the more proximal lumen or located at the tip of an insertablecatheter that can then be removed after performing the soundtriangulation procedure for verification of catheter tip position.

FIG. 8 illustrates a simplified embodiment in which the membrane issituated at the terminal side port of a lumen.

FIG. 9 illustrates the basic configuration of auscultation devices anduser interface.

In FIG. 10 an ultrasound system (20) and transducer (23) are used as anexternal (transcutaneous or transesophageal) energy source.

FIG. 11 illustrates possible ultrasound beam geometry as generated bythe transducer 23, called field of view.

FIG. 12 illustrated the concept of orienting the transducer a minimumdistance from the vessel wall as seen in.

FIGS. 13A and 13B illustrate the concept of aligning the transducer atan angle from the flow axis as shown in.

FIG. 14 shows a transition section made of a relatively much moreflexible material than what the proximal or distal sections are made of.

FIG. 15 shows a concept similar to the transition tube, except that thetransition tube essentially becomes the entire distal section of thecatheter shaft.

FIG. 16 depicts another concept of axial alignment in that instead ofthe distal section being tubing, it is made mostly out of a solidflexible material, such as a polymer.

FIG. 17 shows another concept of axial alignment facilitated by a tethercomponent.

FIGS. 18A and 18B shows a preferred embodiment of two power-injectablelumens each with one side port for fluid delivery adjacent to the closeddistal tip.

FIG. 19 is a side view of a shaft surface-mounted balloon embodiment.

FIG. 20 illustrates a profiled balloon is mounted to the catheter shaftsurface.

FIG. 21 shows an alternate embodiment of a catheter shaftsurface-mounted balloon embodiment with 2 radially asymmetric balloonsplaced on the catheter shaft.

FIGS. 22A, 22B and 22C depict embodiments in which a balloon is mountedonto a catheter shaft such that less than 180 deg, measuredcircumferentially with respect to the catheter shaft, is covered by theballoon material.

FIG. 23 shows an embodiment of the catheter-based flow-directed vascularaccess device in which a flow-directable component.

FIG. 24 shows proximally-actuated and shaft surface-mounted embodimentin which the catheter shaft itself is split such that movement of thedistal tip in a proximal direction will cause the shaft to splay outwardthereby creating a flow-directable component.

FIG. 25 shows yet another proximally-actuated and shaft surface-mountedembodiment in which an umbrella-like component acts as theflow-directable member.

FIG. 26 illustrates that the flow-directable member can be made up ofself-expanding struts covered by a sail material.

FIG. 27 shows another perspective view of another embodiment of adistally-housed flow-directed device that uses an axially-compressedbraid as a flow-directable member.

FIG. 28 shows a perspective view of another embodiment of adistally-housed flow-directed device that uses a balloon as aflow-directable member.

FIG. 29 illustrates a transducer tether embodiment.

FIG. 30A illustrated a sensor may still be positioned against the walleven when the balloon is inflated and when the balloon is mounted toofar proximal on the catheter shaft with respect to the sensor location.

FIG. 30B illustrates one of the ways in which a balloon embodiment canaddress this issue is by being mounted as far distal, with respect tothe sensor, as possible.

FIG. 31 shows a shaft surface-mounted balloon embodiment, building onthe idea described in FIGS. 30A and 30B.

FIG. 32 illustrates a profiled balloon when a flow restriction becomesan issue and prevent the sensor from acquiring a signal.

FIG. 33 illustrated another balloon embodiment may include a balloonmounted entirely on the distal catheter tip, completely covering thesensor.

FIGS. 34A and 34B show a catheter-based vascular access device in whichthe proximal section is made of a relatively stiffer material whencompared to the distal section to facilitate the columnar strengthrequired during distal steering actuation.

FIGS. 35A and 35B show an embodiment of a sensor-directed vascularaccess device in which a mostly circular pre-formed stylet is advancedthrough a catheter lumen to create a passive mechanism by whichtransducer position is maintained so that data can be acquired.

FIGS. 36A and 36B show another embodiment utilizing a pre-formed styletto shape the catheter shaft itself without exiting a side port.

FIG. 37 shows an embodiment of an over-the-wire guidewire-based devicein which the sensor(s) is also mounted on the guidewire.

FIG. 38A shows an embodiment of an over-the-wire guidewire-based devicein which the sensor(s) is mounted on the catheter.

FIG. 38B shows an example of a possible cross-sectional configuration ofthe distal catheter shaft (right-side of Figure) vs. the very distalcatheter tip (left side of Figure).

FIG. 39 shows an embodiment of a rapid exchange guidewire-based devicein which the sensor(s) is again mounted on the guidewire.

FIG. 40 shows an embodiment of a rapid exchange guidewire-based device,as previously described, in which the sensor(s) is again mounted on thecatheter.

FIG. 41 shows another embodiment of FIG. 40 in which one of the distalfluid lumen ports could have a section that is split in a longitudinalfashion as opposed to being completely open.

FIG. 42 shows an embodiment of a sensor-directed guide-wire based deviceadvanced to the target site via active manipulation of the guidewireduring advancement by the user.

FIG. 43 shows an embodiment of a securement device that attaches to theproximal catheter shaft thereby minimizing catheter tip migration fromthe target site.

FIGS. 44A and 44B show top and end views, respectively, of analternative embodiment of a securement device.

FIG. 45 shows an example of workflow tracking on a Vasonova handheldGUI.

FIG. 46 illustrates a VasoNova handheld GUI has a menu feature thatindicates which workflow interval is being tracked and the operator canmodify or change the present task by using the ‘up’ and ‘down’ buttonson the data entry device.

FIG. 47 illustrates a GUI that will display the tasks and with thepresent task highlighted as illustrated in.

FIG. 48 shows the players in a medical workflow.

DETAILED DESCRIPTION

An aspect of the invention includes a transcutaneous ultrasound vascularaccess guiding system comprising: a single element ultrasound deviceproviding A-Mode imaging, Doppler and correlation-based blood velocityestimation; a processor to process and correlate ultrasound information;and a system for information output. The transcutaneous ultrasoundvascular access guiding system may also comprise a lens which controlsthe single element ultrasound beam shape. The transcutaneous ultrasoundvascular access guiding system may also comprise a lens which provides amatching layer between the ultrasound transducer and the skin.transcutaneous ultrasound vascular access guiding system comprising canbe constructed as a single-use device. Also, the information can beoutput as a scrolling chart. The Doppler information can bebidirectional. The Doppler acquisition can be pulsed or continuous wave(PW or CW).

Another aspect of the invention includes an endovascular device guideattached to the imaging device capable of guiding several types ofendovascular devices comprising a needle, a stylet, a catheter, and anintroducer. The device may include adaptors to match the outer diameterof the endovascular guided device to the inner diameter of the guide.The device having the ability to slide or otherwise move with respect tothe imaging device as to provide single hand deployment capability ofthe endovascular guided device.

Another aspect of the invention comprises a method of accessing a bloodvessel comprising the steps of: preparing sterile vascular access siteon patient's skin; sliding an access needle or any other type of accessdevice in the device guide, flush align with the tip of the imagingelement, and lock in position; positioning the assembly on the patient'sskin on the sterile site without the use of ultrasound gel; orientingthe assembly like a flashlight until the desired vessel can be seen onthe scrolling chart display; advancing the endovascular element into thevasculature by sliding the guide element over the imaging device; andmonitoring the advancement of the endovascular device towards thedesired target by using at least one element from a list includingA-mode imaging, Doppler flow information, and/or correlation-based bloodflow information.

Another aspect of the invention comprises an endovascular device capableof emitting audible sounds. The sound emitting element or elements maybe placed anywhere along the endovascular member. The sound generatingelements may be actuated by pushing and pulling wires manually. Thesound generating elements may be actuated by motorized movement ofmoving connective parts. The sound generating elements may be actuatedby delivering a gas through a lumen of the endovascular device. Thesound generating elements may be actuated by delivering fluid through alumen of the endovascular device. The sound generating elements may beactuated through interaction with the blood or anatomical sites. Thesound waves may be generated by rubbing together of notched or serratedcomponents. The sound waves may be generated by hitting a stylet againsta solid member in order to generate a repetitive ping. The sound wavesmay be generated by a moving membrane. The sound waves may be generatedby a moving membrane configured to amplify sound. A device lumen isconfigured to amplify sound.

Another aspect of the invention comprises an auscultation systemcomprising one or more sound sensitive elements. The system includes asound processor and an information output device. The severalauscultation devices can be synchronized to provide acoustictriangulation for accurate detection of the endovascular sound source.

Another aspect of the invention includes a guiding method forendovascular devices comprising the steps of: 1) one or more soundsensitive elements are placed on the patient's chest; 2) the soundemitting endovascular device is inserted in the patient's vasculature;3) The endovascular device emits sound continuously, intermittently oron demand; and 4) Sound sensitive elements detect the sound generated bythe endovascular device. The sound intensity can be used to estimate thedistance between the sound emitting element and the sound sensitiveelement. The sound detected by several sound sensitive elements can betriangulate as to find the location of the sound source with respect tothe sound detecting elements.

Another aspect of the invention includes a method to locate anendovascular device comprising an ultrasound sensor using one or severaltranscutaneous ultrasound systems comprising the steps of: 1)introducing an endovascular member containing an ultrasound sensor intothe vasculature of a body; 2) sending and receiving ultrasound waves inthe vasculature using the ultrasound sensor; 3) placing one or moretranscutaneous ultrasound systems on the patient's body; detecting theinterference between the endovascular ultrasound device and thetranscutaneous ultrasound systems with either the endovascular sensor orwith either of transcutaneous systems; notifying the user wheninterference has been detected such the user becomes aware of thepresence of the endovascular device in the field of view of thetranscutaneous systems. The endovascular device is able to emitultrasound signals. The endovascular device is able to receiveultrasound signals. The transcutaneous ultrasound system is able to emitultrasound signals. The transcutaneous ultrasound system is able toreceive ultrasound signals transcutaneous ultrasound system. Thetranscutaneous ultrasound system can be an ultrasound imaging scan headconnecting to an ultrasound imaging system. Several transcutaneousultrasound systems can be used to triangulate the location of theendovascular ultrasound sensor. The endovascular ultrasound device isconnected to the one or more transcutaneous system such as to allowsynchronization of transmitting and receiving ultrasound waves in thesame region of the body.

Another aspect of the invention includes an endovascular devicecomprising means to separate its tip from the inner blood vessel wallwhile maintaining the blood stream flow. A distal segment of theendovascular device is flexible and made of metal or polymer, and thepolymer may be reinforced to increase tensile strength. The separationfrom the wall is provided by a star shaped balloon. The separation fromthe wall is provided by a 2 piece displaced asymmetrical shaped balloon.The separation from the wall is provided by a deployable circular braid.The separation from the wall is provided by a deployable balloon. Theseparation from the wall is provided by strips cut in the devicematerial and deployed using a deployment member. The separation from thewall is provided by a deployable basket.

Another aspect of the invention includes an endovascular devicecomprising means to align its tip with the blood stream whilemaintaining the blood stream flow. The means comprises axial alignmentthat is facilitated by a tether component. The alignment with the bloodstream is provided by a star shaped balloon. The alignment with theblood stream is provided by a 2 piece displaced asymmetrical shapedballoon. The alignment with the blood stream is provided by a deployablecircular braid. The alignment with the blood stream is provided by adeployable balloon. The alignment with the blood stream is provided bystrips cut in the device material and deployed using a deploymentmember. The alignment with the blood stream is provided by a deployablebasket.

Another aspect of the invention includes a securement device for anendovascular member which provides electrical and optical sensorconnectors and actuation elements to connect and control sensors anddevices attached at the distal end of the endovascular members.

Another aspect of the invention includes a system for tracking clinicalprocedures and improve workflow efficiency comprising: a workflowprocessor; an input interface; an output interface; a code reader; acommunication component; and a database interface. The workflowprocessor stores information about procedure times, device information,patient and operator information, calculates parameters of the procedurelike time duration and elapsed time between activities, and providesstatistical data analysis of such parameters. The information about theendovascular procedure can be input into the system through a dedicateduser interface guiding data acquisition. The output interface presentsresults of procedure workflow analysis. The code reader can be an RFIDreader, a bar code reader or a reader of any computer readable label.The communication component can communicate over the network (wired orwireless) with the hospital information system. The communicationcomponent can communicate with other systems for tracking clinicalprocedures and establish a network of such systems. The databaseinterface allows the procedure and workflow information to be archived.

Another aspect of the invention includes a method for tracking clinicalprocedures and improve workflow efficiency comprising the steps of: 1)Input to the time when a consult request has been received; 2) Input thetime when a work step is started; and 3) Input the time when a work stepis finished. The a work step comprises the following activities:

a. Gather patient data (check history, allergies, lab results, etc)

b. Transportation to case (cart/supplies)

c. Obtain patient consent

d. Gain vascular access, e.g., venipuncture

e. Place endovascular device or any other type of device

f. Provide therapy through the endovascular device

g. Remove or secure the endovascular device

h. Order/wait for x-ray or other confirmatory imaging modality

i. Reposition device in case x-ray does not confirm location; and

j. Document that endovascular device is ready for use

1.0 System for Guided and Sterile Vascular Access

Aspects of the following embodiments may share some or all of thefollowing characteristics such as disposable imaging device, an imagingdevice with a needle guide and the ability to cannulate a vessel in asingle disposable sterile bag or container.

Free-Hand A-Mode Imaging

The free-hand A-mode imaging preferably includes a disposable,inexpensive, accurate vascular placement device that reduces access timeas compared to conventional vascular placement devices and methods. Thefree-hand A-mode imaging preferably enables a procedure for bedsidecentral line placement.

The patient's arm and axilla/shoulder are prepped in the usual sterilefashion. A ribbon of latex or other type tourniquet is used on the upperarm to help distend the veins.

FIG. 1 illustrates a disposable or reusable imaging and guiding devicefor vascular access. The device in FIG. 1 includes an elongate body 13,guide 11, a needle 1, an introducer 2, a dilator 3, an access wire 4, acatheter 5, a handle 7 and an ultrasound transducer 502. In particular,FIG. 1 illustrates an A-mode device that has a pencil or other shapedhandheld device with the ultrasound device (i.e., disposable ultrasoundtransducer 502) at a distal tip, which may be perpendicular or at a 30,45, 60 or other degree angle relative to an axis of the handheld device.A needle 1/guide 11 or catheter 5/needle 1 combination may also beconfigured as part of the device such that a beam 12 of the ultrasoundtransducer 502 crosses a set needle path as it pierces skin 9 andtraverses subcutaneous tissues. This arrangement allows an operator tovisualize the needle 1 as it punctures a blood vessel 6 of interest. Thedevice presented in FIG. 1 may be delivered in a sterile package and isdisposable.

Once a most superficial wall of a vein has been punctured a flash ofblood is visualized at a hub end of the catheter 5/needle 1. The accesswire 4 is then advanced through the needle 1 and the catheter 5 (ifpresent) is then advanced over the access wire 4 into the blood vessel6. The guiding device, needle 1/access wire 4 (as in an Angiocathcombination) is then removed, leaving in place only the catheter 5. Thecatheter 5 is of sufficient size to allow passage of a larger accesswire 4, 0.035″ or larger for example, to enable placement of a peel-awaysheath and dilator 3. The dilator 3 and access wire 4 are then removedand the PICC is inserted through the peel-away sheath. Alternatively,access wire 4 is advanced into the blood vessel 6 through the needle 1and no Angiocath is utilized. The guiding device and needle 1 are thenremoved and the peel-away sheath and dilator 3 are advanced over theaccess wire 4. Once the sheath is all the way in the dilator 3 andaccess wire 4 are removed and the PICC is inserted through the peel-awaysheath.

The guiding device connects to a VasoNova handheld with GUI by a cord orwith wireless connectivity. The guiding device may be disposable orsterilizable/reusable. The catheter 5/needle 1/access wire 4 componentis disposable and may be integrated with the ultrasound device if thecatheter 5/needle 1/access wire 4 is disposable. The catheter 5/needle1/access wire 4 may be inserted or attached to a reusable ultrasounddevice. The primary ultrasound modality is A-mode for visualizing thetissues on gray-scale with real time analysis; however the modality canalso be switched manually or automatically to Doppler mode within theblood vessel lumen to confirm venous flow versus arterial flow based onvelocity of blood flow and pulsatility pattern.

A handheld component of ultrasound-guided blood vessel access system maybe ergonomically designed in order to optimize user positioning andangle of contact with the patient's skin. This may involve placing theultrasound device in an enclosure that resembles a computer mouse, apencil-shaped device, short stubby cylindrical device or other shapedhandheld that can also incorporate the needle 1/access wire 4introduction system as described above. The device may provide for theability to swivel the ultrasound and needle guiding components tooptimize position relative to the portion that is held in place by theoperator and the blood vessel to be punctured.

The ultrasound-guided blood vessel access system is not exclusivelyintended for use in placing PICCs. The ultrasound-guided blood vesselaccess system may also be used for blood vessel puncture in general whenthe blood vessel of interest is not visible or easily palpable to theoperator's satisfaction and ultrasound confirmation and guidance isdesired for puncturing the blood vessel. As such the ultrasound-guidedblood vessel access system may be used for accessing veins, such asperipheral veins such as the cephalic, basilica, median cubital,brachial, antecubital, or other veins of the arm, the long and shortsaphenous or other superficial veins in the legs, or for accessing morecentrally located veins such as axillary, subclavian, internal orexternal jugular veins, or common femoral veins for example. Theultrasound-guided blood vessel access system may be used to identifyarteries such as the radial, ulnar, brachial, axillary, femoral, orother for puncture or simple detection of blood flow, such as with a“Doppler check” as when a nurse assesses a patient's arterial blood flowin an extremity after a vascular operation during the postoperativephase.

1.1 Ultrasound-Guided Apparatus and Method for Blood Vessel Access TheApparatus

As noted above, the apparatus in FIG. 1 includes an elongate body 13,guide 11, a needle 1, an introducer 2, a dilator 3, an access wire 4, acatheter 5, a handle 7 and an ultrasound transducer 502. The apparatusillustrated in FIG. 1 includes a single element imaging elementcomprising a body 13, shaped like a pen or a flashlight. The singleelement imaging element consist of a handle 7 and an ultrasoundtransducer 502. The ultrasound transducer 502 emits a single beam 12 andcan consist of a single or multiple elements, e.g., piezoelectriccrystals. The beam 12 can be focused, unprocessed, or divergent.Frequency of operation should be such as to allow near field imaging andpenetration to the vessels of interest for cannulation, for example 7 to10 MHz.

The apparatus contains further a detachable or fixed guide 11 whichallows for sliding a needle 1, a dilator 3, an access wire 4 or acatheter 5 through the guide 11 into the blood vessel 6 and into thefield of view of the ultrasound beam.

The apparatus is further capable of providing blood flow velocity anddirection information using non-directional or bi-directional CW or PWDoppler or cross-correlation methods similarly to the system describedin the VasoNova patent applications.

The ultrasound device (i.e. ultrasound transducer 502) is connected toan instrument for processing (i.e., processor) and displaying singlebeam ultrasound images in an amplitude (A-Mode) display. The type ofvascular access imaging may be free hand A-Mode obtained with thedevice. The imaging may be color A-mode imaging, whereby the colorsindicate bidirectional blood flow velocities obtained using Doppler orcross-correlation calculations, or duplex A-Mode imaging mode, where thebidirectional Doppler spectral distribution (velocity distribution) isin a sample window.

The handle 7 further comprises one or more buttons that allow for singlefinger operation of any component controlled by the handle 7, e.g.,turning the Doppler mode on and off or adjusting the depth of the samplewindow.

The guide comprises a lumen adaptor to accommodate different sizedevices, such as for example, a dilator, an access wire, a catheter andthe like.

Guided Cannulation Method

In one embodiment, a guided cannulation method includes the followingsteps:

-   -   1. Prepare the sterile field for cannulation;    -   2. Connect the sterile apparatus to the ultrasound device;    -   3. Use the apparatus like a flashlight to look for a target        vessel using A-Mode imaging;    -   4. Optionally use Doppler to double check if the target vessel        is a vein or an artery based on flow characteristics;    -   5. Attach the needle 1 to the guide 11 and insert needle 1 until        needle 1 can be seen on the A-Mode image as reaching the vessel        of interest. Insert the access wire 4, dilator 3/introducer 2        and any other desired endovascular member under ultrasound        visualization; and/or    -   6. Detach the apparatus from the inserted endovascular member,        disconnect from the ultrasound device and dispose of the single        use component.

2.0 Guided Endovascular Access Device

2.1 Energy Element (Sensor and Source)

2.1.1 Acoustic Triangulation

Sound waves are generated at the catheter tip and detected bystrategically placed electronically amplified auscultation devices thatare in contact with the patient's skin.

The sound waves may be generated by the mechanical interaction of solidcomponents, by transduction of vibrational energy along a stylet, byvibration of valve flaps near the catheter tip, or by pneumaticactivation of a membrane that is at the interface of a gas or liquidfilled catheter lumen/cavity and the patient's blood.

Interaction of solid components may involve rubbing together of notchedcomponents at the catheter 500 tip with similar notched element 14 orserrated components at the distal end of a stylet 12 that passes throughone of the catheter lumens 10 (FIG. 2). FIG. 2 includes a catheter 500,a catheter lumen 10, a stylet 12, a notched element 14 within catheterlumen 10, a notched member 14, sound waves 16, motion of stylet 12 tocreate sound waves 16 and notched element 14 on stylet 12 to interactwith notched element 14 in catheter lumen 10. This type of sound wave 16generation is similar to stridulation in certain insect species that userubbing together of exoskeletal prominences to create sound that isnecessary for identifying the location of potential mates. To generatethe sound, the stylet 12 must be advanced forward and backward in rapidsuccession. In order to accomplish the necessary motion, the end of thestylet 12 at the hub end of the catheter 500 may be attached to amotorized device that can move the stylet 12 the correct distance, whichmay be from less than one centimeter of displacement up to 2 centimetersand at the correct speed in order to optimize the sound that is created.

Another method of sound generation may involve the stylet 12 hittingagainst a solid member at the catheter 500 tip to generate a repetitiveping. This vibratory sound generation would require that the stylet 12be actuated or maneuvered by a motorized process that is controlled atthe proximal end of the stylet 12, which is outside the patient. Thestylet 12 is attached to a motorized device that will cause the styletto move in the appropriate direction and the appropriate distance inorder to optimize the sound. FIG. 3 shows an embodiment in which themotion required is perpendicular to the stylet 12 axis and FIG. 4 showsan embodiment in which the motion required is parallel to the stylet 12axis. FIG. 3 includes catheter 500, catheter lumen 10, stylet 12, soundwaves 16, stylet tip 22, solid members 20, striker 24 and motion ofstriker 24 to create sound waves 16. FIG. 4 includes catheter 500,catheter lumen 10, stylet 12, sound waves 16, stylet tip 22, solidmember 20, striker 24 and motion of striker 24 to create sound waves 16.

If a vibrating valve is used to produce sound, motion of a valve flap 30or valve flaps 40 is induced by the rapid injection of a liquid or gassuch as CO₂ through the catheter lumen 10 within which valve resides(FIGS. 5 and 6). FIG. 5 includes catheter 500, catheter lumen 10, soundwaves 16, single flap valve 30 and gas/fluid flow path 32. FIG. 6includes catheter 500, catheter lumen 10, sound waves 16, valve flaps 40and gas/fluid flow path 32. The sound generated by the flap motion maybe amplified by the shape of the more distal catheter lumen 10 and exitport distal to the flap as illustrated in FIG. 7. FIG. 7 includescatheter 500, catheter tip 46, amplified channel or chamber 48, gasfilled lumen 42, membrane 44 and amplified sound waves 46 from membrane44.

If a pneumatic system is employed, the catheter lumen 10 that is incontact with the membrane 44 at the catheter 500 tip is attached at thecatheter 500 hub to a gas compressor device that causes rapid pneumaticpressure fluctuation, thereby distending the membrane 44 at an optimalfrequency, thereby generating a sound wave that propagates through thepatient's blood and adjacent soft tissues such that it can be detectedby the auscultation devices that are placed on the patient's skin. FIG.8 illustrates a simplified embodiment in which the membrane 44 issituated at the terminal side port of a lumen 10. FIG. 8 includescatheter 500, catheter tip 46, gas filled lumen 42, membrane 50, soundwaves 16 and side port 52. FIG. 7 illustrates an embodiment, in which aconvoluted lumen 10 acts as an amplifier, thus enabling a smaller sizedmembrane 44 that can be positioned in the more proximal lumen or locatedat the tip of an insertable catheter 500 that can then be removed afterperforming the sound triangulation procedure for verification ofcatheter tip position.

The sound waves that are generated by all methods described above areoptimized for best detection by the amplified auscultation devices thatare placed on the patient's skin by means of an adhesive attachment. Theplacement of the auscultation devices may be such as to optimize sounddetection and triangulation to determine the sound source. For example,auscultation detectors should be placed in areas that will permitpropagation of the sound waves in a direct path through solid tissuefrom the source to the detector instead of areas of the skin where adirect path from the catheter tip to the detector would pass throughlung tissue for example. Potential ideal locations for detecting soundgenerated within the caval-atrial junction or lower ⅓ of the IVC along adirect path include but may not be limited to:

-   -   1) skin overlying the right internal jugular vein at the base of        the neck,    -   2) skin overlying the right 4th intercostals space adjacent to        the sternum,    -   3) skin overlying over the ipsilateral and/or contralateral        subclavicular space (relative to the side of catheter insertion)        at the junction of the medial ⅔ and lateral ⅓ of the clavicle,        two fingerbreadths below the clavicle.

Detected sound frequencies and amplitudes are analyzed and processed bythe handheld system according to specific algorithms and a the soundsource is displayed on the handheld GUI, with the source shown relativeto the auscultation devices that are depicted as reference points on agraphical human torso. FIG. 9 illustrates the basic configuration ofauscultation devices and user interface. FIG. 9 includes a patient 64,auscultation devices 66, position 1, position 2, position 3, leads 68,location of sound source 62, display 60, processor 70 and image 71 onGUI as a result of processing.

2.1.2 Interaction with Transcutaneous Energy Source

An aspect of the invention relates to using two or more focused energytransmitters and receivers in order to detect each others presence ineach others field of view. The overlap region between the fields of viewof the two or more energy elements is indicative of the relativelocation of the energy elements with respect to each other. Techniquestriangulation (Brisken), marking with active/passive elements (Breyer),synchronized imaging (Frazin).

Aspects of the following embodiments share some or all of the followingcharacteristics:

1. Use of the effect of interference between two ultrasound energyelements on the Doppler frequency shift. The Doppler capable detectingelements detects the presence of the other element or of the energyemitted by the other element in its field of view by detecting artifactsin the Doppler frequency shift.

2. Visualization of small targets without requiring synchronizationbetween energy elements.

3. Use of an endovascular element to detect the presence of the field ofview of the imaging device.

4. The ability of an endovascular Doppler sensor to detect Dopplerfrequency shifts as a result of interference with another ultrasoundenergy source working at a different frequency and unsynchronized.

5. Methods to determine position of an energy element in the anatomywithout X-ray imaging, without expensive automatic triangulation andwith the accuracy of the region of overlap between the fields of view ofthe two energy elements.

These and other aspects of the various embodiments of the invention willbe appreciated in the description that follows.

FIG. 10 includes an external ultrasound system 20, transducer 23, wire21, endovascular ultrasound system 25, endovascular probe 24, externalconnection 26 and patient 22. In FIG. 10 an ultrasound system (74) andtransducer (23) are used as an external (transcutaneous ortransesophageal) energy source. The system (20) may be Doppler capable.An endovascular probe (24, catheter, wire, stylet) has an ultrasoundsensor attached to it and is connected to a Doppler capable ultrasoundsystem (25). The external and the endovascular Doppler systems may besynchronized via an external connection (26).

The system (20) may be one like the Bard SiteRite (www.bardaccess.com)or the SonoSite iLook (www.sonosite.com) system working at frequenciesbetween 4 and 8 MHz. The Doppler endovascular probe (24) may work at 10MHz and be similar to those described in the VasoNova patentapplications.

FIG. 11 illustrates possible ultrasound beam geometry as generated bythe transducer 23, called field of view. FIG. 11 includes transducer 23,sensor 27 and axis 28. FIG. 11 also illustrates the ultrasound beamgeometry (field of view) generated by the ultrasound sensor of theendovascular probe. When the field of view of the endovascularultrasound sensors overlaps with the field of view of the transducer(23) energy interference patterns can be detected by both systems.

The interference patterns may be created either a) by direct transfer ofenergy from one ultrasound sensor to another in the field of view or b)through perturbations in the medium created by one sensor which aredetected by the other sensor. For example, the transducer (23) cangenerate waves in the blood within the vessel where the endovascularprobe resides and the endovascular Doppler sensor detects the effect ofsuch waves on blood. The interference, i.e. the transfer of acousticenergy may occur at the central or harmonic frequencies as well as atany other resulting interference frequency which is within the bandwidthof the individual ultrasound sensors.

Interference patterns are detected by the system (20) through the sensor(23). Additionally or alternatively the interference patterns may bedetected by the endovascular ultrasound Doppler system.

In one embodiment an ultrasound imaging system like SiteRite or SonoSiteis used to image the heart towards the caval-atrial junction. Anintravascular device (catheter, wire, and stylet) with a Doppler-capablesensor is inserted through the vasculature and guided towards the heart.The endovascular sensor is connected to a Doppler system which producessignals in accordance with the Doppler frequency shift detected by thesensor. When the endovascular sensor navigates through a vessel, e.g.,the SVC and the caval-atrial junction, which is in the field of view ofthe imaging transducer, the energy emitted by the imaging transducerinterferes with the energy emitted by the endovascular probe and theDoppler system connected to the endovascular probe generates signalpatterns representative of the interference. Based on these patterns, auser observing the Doppler signals generated by the endovascular probecan infer that the endovascular sensor is situated in the field of viewof the imaging probe looking towards the caval-atrial junction. Thus theposition of the sensor in the caval-atrial junction is confirmed withouthaving to visualize the catheter in the ultrasound image and without theneed of a chest X-ray.

In a further embodiment a Duplex ultrasound imaging system like theAspen model from Acuson Siemans, Inc. (Mountain View, Calif.) isoperated in a Duplex mode: simultaneous imaging and pulsed wave (PW)Doppler or continuous wave (CW) Doppler. The 2D imaging window can showthe blood vessel where the endovascular probe is located and the Dopplerwindow shows the Doppler velocity information. In PW mode the samplewindow is shown over the 2D image. When the endovascular sensor is inthe field of view of the CW or in the sample window of the PW mode, aDoppler artifact showing velocity patterns representative of theinterference between the two energy elements is shown in the Dopplerwindow. Thus the position of the endovascular sensor is detected.

In a further embodiment a transcutaneous CW or PW pencil probe is usedto monitor blood flow in a peripheral blood vessel, e.g., the internaljugular vein. A Doppler-capable endovascular probe is advanced throughthe internal jugular vein. When the endovascular and the transcutaneousprobes are within the field of view of the other, each detects Dopplervelocity artifacts representative of the interference patterns. Asimilar technique applies in the case of multiple endovascular probes.

In a further embodiment the two or more energy elements can besynchronized, such that one emits at a certain delay with respect to theother, e.g., in the receive window of the other. This allows forcalculating the distance between probes by knowing the transmit delayand assuming a certain velocity in the anatomy. Thus depth and distanceseparation/resolution can be achieved. The two energy elements cancommunicate with each further using coded excitation. If one of theelements generates a certain code pattern, the other one receiving itcan identify the presence and location of the transmitting element.

In a further embodiment several locating energy elements can be used tocalculate the location of a target energy element by usingtriangulation. In such a situation the multiple locating elements servealso as reference or as a coordinate system. Alternatively only onelocating energy element can be used to locate a target energy element bytriangulation if the locating element is moved from place to place in acontrolled manner; such that each time the target is located theposition is calculated and stored. After a number of such computationstaken with the same locating element at different times and fromdifferent locations, the position of the target can be reconstructed. Insuch a case the reference/coordinate system is determined by anatomicallandmarks relative to which both the single locating element and thetarget can be positioned.

2.2 Transducer Placement Concepts

There exist at least two important concepts with respect to optimizingdata acquisition from the transducer: radial distance from the insidevessel wall, and axial alignment with respect to blood flow. Each factorinfluences the quantity and quality of data acquired by the ultrasoundtransducer.

2.2.1 Radial Distance

Fluid flowing through the inner diameter of a lumen has differentcharacteristics with respect to flow velocities nearer to the vesselwall than farther towards the center of the lumen: the flow may be moreturbulent and slower at the periphery. To take advantage of this knowndifference thereby avoiding undesirable data acquisition, is the conceptof orienting the transducer a minimum distance from the vessel wall asseen in FIG. 12. FIG. 12 includes catheter shaft 500, ultrasoundtransducer 502, transducer beam 504 and vessel wall 510.

The minimum distance, x, may be determined empirically, or it may bedetermined by traditional fluid dynamics calculations. This distance maybe expressed as a percentage of the lumen diameter, or it may be anabsolute number irrespective of lumen dimension.

This application describes several concepts of achieving this radialdistance in the following device embodiments.

2.2.2 Axial Alignment

Fluid flowing through the inner diameter of a lumen has a ‘preferred’axis of flow that mostly follows the shape of the vessel axis it isflowing within. This preferred axis may be described as that whichfacilitates the largest magnitude velocity flow vector. Therefore,different characteristics with respect to flow velocities may be foundas alignment shifts in an angular sense from the central vector. To takeadvantage of this known difference thereby avoiding undesirable dataacquisition, is the concept of aligning the transducer at an angle fromthe flow axis as shown in FIGS. 13A and 13B. FIGS. 13A and 13B includevessel wall 510, transducer 502, transducer beam 504, catheter shaft500, transducer axis 506 and fluid flow axis 508.

The axial offset angle may be expressed as an angular value, α, and thismay again be empirically determined or be expressed by traditional fluiddynamics calculations. The angle may be expressed as a percentage ofvessel curvature, or it may be an absolute irrespective of vesselconfiguration.

Several general concepts of achieving this axial alignment can beapplied to the embodiments described in this application. Theseembodiments allow for a more flexible portion of the device justproximal to the transducer, and relative to the remaining portion of thecatheter, that can be manipulated by the flow in the vessel. Becausethese sections are able to be biased by fluid flow, the transducer ismore likely to find a position in the position of maximum flow.

FIG. 14 shows a transition section 522 made of a relatively much moreflexible material 528 than what the proximal 520 or distal 524 sectionsare made of. FIG. 14 includes catheter shaft 500 comprising a proximalsection 520, transition section 522, distal section 524, flexiblematerial 528 and ultrasonic transducer 502. However to prevent likelykinking of a softer material is the concept of sandwiching a stiffeningmember to provide maximum kink-resistance yet impact flexibility aslittle as possible. This may be accomplished with a coil or braid orother axially-involved members. The stiffening material may be metallicor polymeric in nature.

FIG. 15 shows a concept similar to the transition tube, except that thetransition section essentially becomes the entire distal section 524 ofthe catheter shaft 500. FIG. 15 includes catheter shaft 500 comprising aproximal section 520, distal section 524, flexible material 528 andultrasonic transducer 502. Again, this could be reinforced with a coilor braid of a metal or a polymer.

FIG. 16 depicts another concept of axial alignment in that instead ofthe distal section 524 being tubing, it is made mostly out of a solidflexible material, such as a polymer. FIG. 16 includes catheter shaft500 comprising a proximal section 520, distal section 524, flexiblematerial 528 and ultrasonic transducer 502.

FIG. 17 shows another concept of axial alignment facilitated by a tethercomponent. The tether is again very flexible in nature and affixedtightly to the distal end of the proximal shaft. FIG. 17 includescatheter shaft 500 comprising a proximal section 520, tether 526 andultrasonic transducer 502. The tether can be made of metal or polymer,and the polymer may be reinforced to increase tensile strength.

2.3 Catheter Type

Embodiments of the inventive device include three basic forms:catheter-based, stylet-based & guidewire-based. Some embodiments of thevascular access device may be considered catheter-based, utilizing noremovable components. Other embodiments are stylet-based, utilizing aremovable component designed to work within the catheter. Otherembodiments are guidewire-based, utilizing a removable componentdesigned to work without the catheter. Combinations of the three basicforms are also possible.

Fluid delivery can be achieved through the catheter shaft in any of theconfigurations described here within in a number of ways. In a preferredembodiment, the catheter has a closed distal end, is power-injectableand has distal side ports for fluid delivery. These side port(s) can belocated along the catheter shaft to comply with pressure and flow raterequirements as well as to provide for optimal access location. Eachlumen can have one or more ports and each catheter can have one or morelumens. FIGS. 18A and 18B show preferred embodiments of twopower-injectable lumens each with one side port for fluid deliveryadjacent to the closed distal tip. In another preferred embodiment, thepower-injectable catheter has fluid ports that exit straight out thedistal catheter tip. FIG. 18A includes catheter shaft 500, ultrasonictransducer 502, braid 538, fluid 530, ECG 534 and actuation tube 532.FIG. 18B includes a distal section 524, ultrasonic transducer 502, braid538, fluid 530, ECG 534 and actuation tube 532.

2.3.1 Catheter-Based

Catheter-based devices are “all-in-one” type devices in which nocomponent is completely removable. These remain entirely intact duringcatheter advancement, drug delivery and subsequent implant dwell time.

Embodiments of the catheter-based inventive device include three basicforms: flow-directed, sensor-directed (passive) and sensor-directed(active). Some embodiments of the catheter-based vascular access devicehave catheter tips directed mostly by fluid flow within the vasculature.Other embodiments are passively directed by the sensor(s) duringcatheter advancement through the vasculature. Other embodiments requireactive manipulation of the catheter tip to acquire and or optimize thedata collected by the sensor(s).

2.3.1.1.1 Flow-Directed

In the flow-directed embodiments of the catheter-based vascular accessdevice, placement of the device is ‘automatic’ in that minimal userinteraction is required to position the catheter at the target site. Thecatheter is positioned ‘automatically’ by utilizing the blood flowingadjacent to and around it. The sensor(s) are therefore used to verifycatheter tip placement at the desired target site as opposed toproviding information during advancement to facilitate the advancementitself.

2.3.1.1.1 Shaft Surface-Mounted, Balloon Embodiments

In these embodiments, blood flow is utilized by way of a flow-directablemember mounted onto the catheter shaft surface that takes the form of aballoon. The balloon is inflated from a proximally-located port bytechniques well-known to those skilled in the art of balloon catheters.

FIG. 19 is a side view of a shaft surface-mounted balloon embodiment.FIG. 19 includes vessel wall 510, catheter shaft 500, transducer 502 andballoon 540. The balloon 540 material, either compliant ornon-compliant, is mounted onto the catheter shaft 500, and thetransducer 502 is left at the distal tip. In one embodiment, the balloon540 is considered symmetrical in both the axial and radial directions.Balloon embodiments may impede blood flow around the transducer causinga signal substandard to that which could otherwise be obtained were moreblood allowed to flow around and adjacent to the transducer. In anotherembodiment, a profiled balloon 540 is mounted to the catheter shaft 500surface, as shown in the side and end views of FIG. 20. FIG. 20 includesvessel wall 510, catheter shaft 500, transducer 502 and balloon 540. Itis believed that the profiled shape facilitates blood flow near thetransducer 502.

FIG. 21 shows an alternate embodiment of a catheter shaft 500surface-mounted balloon embodiment with 2 radially asymmetric balloonsplaced on the catheter shaft 500. FIG. 21 includes catheter shaft 500,transducer 502 and proximal balloon 540 and distal balloon 542. From aradial perspective, the flow is circumferentially captured to maximizethe use of a balloon 542 or 544 as a sail. The balloons 542 and 544 arestaggered from an axial point of view to facilitate more blood flowaround and adjacent to the transducer. While two balloons are shown,more or less may be used.

FIGS. 22A, 22B, and 22C depict embodiments in which a balloon 586 ismounted onto a catheter shaft 500 such that less than 180 degree,measured circumferentially with respect to the catheter shaft 500, iscovered by the balloon material. FIGS. 22A, 22B and 22C include vesselwall 510, catheter shaft 500, transducer 502, balloon 586, strap 584 andbeam profile 590. A non-distensible member, i.e. a ‘strap’ 584, isplaced over the balloon 586 in an axial direction to facilitate mostlycatheter 500 shaft bending and minimally balloon 586 inflation. Theassembly is straight when the balloon 586 is uninflated. Once inflationis complete, the distal catheter 500 shaft is deflected and becomes aflow-directable member, thereby moving the catheter tip into the bloodflow facilitating movement through the blood vessel.

2.3.1.1.1.2 Shaft Surface-Mounted, Non-Balloon Embodiments

In these embodiments, blood flow is utilized not by balloons, but byflow-directable members mounted onto the catheter shaft surface andactuated from the proximal handle via several methods well-known tothose skilled in the art of catheter actuation, i.e.: push/pull tube orwire, outer diameter sheath, etc.

FIG. 23 shows an embodiment of the catheter-based flow-directed vascularaccess device in which a flow-directable component, shown in the figureas an axially-compressed braid 544, is mounted directly on the exteriorsurface of the catheter 500 shaft. FIG. 23 includes catheter shaft 500,ultrasonic transducer 502, braid 544, fluid 530, ECG 534. In oneembodiment, the braid 544 component is manufactured in such a way suchthat the radial expansion of the fibers is maximized. The braid 544material can be metallic or polymer-based. The amount of flow capturedby the braid 544 can be varied depending upon the number of filamentsused or the diameter of same.

FIG. 24 shows another proximally-actuated and shaft surface-mountedembodiment in which the catheter 500 shaft itself is split such thatmovement of the distal tip in a proximal direction will cause the shaft500 to splay outward thereby creating a flow-directable component. FIG.24 includes catheter shaft 500, transducer 502, strip 552.

The flow-directability of any of the configurations described in theprevious figures can be augmented by placing a covering of some sort tocapture more of the flow. The amount captured may be fine-tuned byvarying such features as the density (i.e.: placing perforations in thematerial), or flexibility as well.

FIG. 25 shows yet another proximally-actuated and shaft surface-mountedembodiment in which an umbrella-like component acts as theflow-directable member. FIG. 25 includes catheter shaft 500, transducer502, umbrella 554.

2.3.1.1.2 Tip-Mounted Embodiments

In these embodiments, blood flow is utilized by way of a flow-directablemember mounted directly onto the catheter tip instead of the shaftsurface.

Any of the configurations shown in FIGS. 15, 16 and 17 as alignmentexamples are also candidates for embodiments relating to tip-mounting,with no retraction. The concept is that the lighter the transducerassembly is, the more likely it will be to float in the vasculature.

2.3.1.1.2.1 Distally-Housed Embodiments

In these embodiments, blood flow is again utilized by flow-directablemembers, but instead of being mounted onto the catheter shaft surface,they are mounted to an internally-based actuation tube that is actuatedfrom the proximal handle via methods well-known to those skilled in theart of catheter actuation. Once the flow-directable member is no longerneeded, it may be retracted into the distal catheter shaft.

FIG. 18A shows a perspective view of an embodiment of the flow-directedcatheter-based vascular access device in which a flow-directablecomponent is ‘housed’ inside the distal end of a catheter shaft. In thisparticular embodiment, the flow-directable component is an open-endedbraid shaped similar to the ‘Lacrosse’ basket. It is predisposed to anexpanded or open configuration, and collapses when pulled inside thedistal catheter housing. The transducer is mounted within the braid, andboth are mounted onto an actuation tube. The actuation tube houses thetransducer wire and the ECG wire as well. The braid and actuation tubemay be made entirely out of a polymer, entirely out of a metal or acombination of both. If the tube was made of a conductive material orencapsulated a conductor of some sort, it could double as the ECG leadas well. The actuation tube is actuated from the proximal catheterhandle.

In this particular embodiment, the braid is designed such that itcaptures the majority of blood flowing through the lumen, in order tofacilitate movement of the device through the vasculature, yet stillallows enough blood to flow through it to provide data for thetransducer to utilize. This concept may facilitate device movement inthe correct direction (with flow), averting the need to influence orsteer the tip. Then as the need for influencing or steering the tipdiminishes, the importance of catheter shaft torque-ability is alsoreduced. This in turn facilitates the use of a softer, more flexiblecatheter shaft compliant to the vessel and more comfortable to thepatient.

FIG. 18B shows a close-up cross-sectional view of the distal cathetershaft of FIG. 18A. The catheter shaft is made of a proximal and distalsection. The proximal section is made up of at least 3 lumens: two forseparate fluid delivery ports and one for the actuation tube. The distalsection may be a single lumen tubing that ‘houses’ the collapsed braid.

By relocating the fluid ports just proximal of the distal ‘house’ (asshown in FIG. 18B), precious catheter ‘real estate’ is optimized: thedistal section is reserved for a bulky flow-directable member, while theslimmer actuation member follows the fluid lumens back to the proximalhandle.

The ‘Lacrosse’ braid design may be made by turning a simple braided tubeback onto itself. In this configuration, the very distal or mostexpanded end may be difficult to retract into the housing in terms ofthe pull force required. To minimize this force, the very distal end maybe asymmetrical in nature so that the entire circumference isn't pulledinto the distal house concurrently.

Alternatively, the flow-directable member can be made up ofself-expanding struts covered by a sail material, such as abiocompatible flexible material, e.g., ePTFE or other suitablebiocompatible sheet, as shown in FIG. 26. FIG. 26 includes distalcatheter shaft 500, transducer 502, struts 562, sail basket 560 andactuation tube 564.

FIG. 27 shows another perspective view of another embodiment of adistally-housed flow-directed device that uses an axially-compressedbraid as a flow-directable member. FIG. 27 includes distal cathetershaft 500, transducer 502, braid 544 and actuation tube 564.

FIG. 28 shows a perspective view of another embodiment of adistally-housed flow-directed device that uses a balloon as aflow-directable member. FIG. 28 includes distal catheter shaft 500,balloon 570, transducer 502 and actuation tube 572. In this concept, thedistal catheter section may not facilitate collapse of theflow-directable member, as in the case of the other describedembodiments, it may simply house the flow-directable member.

In any of the described configurations, the transducer may be mounted onthe flow-directed component in such a way to optimize the signalacquired, in other words, distal to the component or so that thetransducer signal is not attenuated by the component's presence.

Alternatively, the transducer could be mounted on a tether (aspreviously described in FIG. 20). FIG. 29 illustrates a transducertether embodiment. FIG. 29 includes distal catheter shaft 500,transducer 502, tether 573 and actuation tube 564.

2.3.1.2 Sensor-Directed (Passive)

In the passive sensor-directed embodiments of the catheter-basedvascular access devices, placement of the device is facilitated by datareceived passively from the sensor(s) located on the catheter shaftduring catheter advancement. User interaction is required to advance thecatheter according to the data received and displayed by the sensor(s),and the sensor(s) are again used to verify catheter tip placement at thedesired target site. However, no user interaction is required tooptimize the sensor(s) information received in these embodiments: thisfunction is passively accomplished by virtue of the catheter design.

To accomplish passive acquisition of sensor data or data acquisitionthat does not require user interaction to facilitate either its basicacquisition or optimization of, the distal catheter design needs toaccomplish two things. First, the distal catheter design needs tofacilitate placement of the sensor a minimum distance, when measuredradially, from the vessel wall to insure that enough flow, as well assteady flow is experienced in the area directly adjacent to the sensor(as described in section 2.3.1). Second, the distal catheter designneeds to facilitate axial alignment of the ultrasound sensor withrespect to the flow of blood adjacent to it (as described in section2.3.2).

Shaft Surface-Mounted Balloon Embodiments

In these embodiments, radial distance from the vessel wall and/or axialalignment is achieved by a balloon member mounted onto the cathetershaft. The balloon is inflated from a proximally-located port bytechniques well-known to those skilled in the art of balloon catheters.

FIGS. 19, 20 and 21, as previously described, are examples ofshaft-mounted balloon embodiments that could facilitate radial distancefrom the vessel wall.

One of the challenges in achieving the desired radial distance with theembodiments shown in FIGS. 19 and 20 is when the tip is adjacent to thevessel wall 510 while in a curve. As illustrated in FIG. 30A, when theballoon 576 is mounted too far proximal on the catheter shaft 500 withrespect to the sensor location, the sensor may still be positionedagainst the wall 510 even when the balloon is inflated. One of the waysin which a balloon embodiment can address this issue is by being mountedas far distal, with respect to the sensor, as possible, as shown in FIG.30B. Both FIGS. 30A and 30 B include catheter shaft 500, transducer 502,balloon 576, vessel wall 510.

FIG. 31 shows a shaft surface-mounted balloon embodiment, building onthe idea described in FIGS. 30A and 30B, in which the balloon 540 ismounted on the catheter shaft 500 so that it extends distally beyond thelocation of the sensor.

Should flow restriction again become an issue and prevent the sensorfrom acquiring a signal, as previously described, a profiled ballooncould be used as shown in FIG. 32.

Another balloon embodiment may include a balloon mounted entirely on thedistal catheter tip, completely covering the sensor, as shown in FIG.33. In this embodiment, the balloon 582 would need to be filled with amedium transparent to the ultrasound frequencies of the sensor used,i.e.: saline or water.

Further, any of the balloon embodiments could offer adjustable radialdistances depending upon the amount of fluid injected into the proximalport and the resulting amount of balloon inflation.

Shaft Surface-Mounted, Non-Balloon Embodiments

In these embodiments, radial distance from the vessel wall and/or axialalignment is achieved by radially expanding members mounted onto thecatheter shaft surface and actuated from the proximal handle via severalmethods well-known to those skilled in the art of catheter actuation,i.e.: push/pull tube or wire, outer diameter sheath, etc.

FIGS. 23, 24 and 25, previously described, show embodiments ofcatheter-based and sensor-directed vascular access devices in whichshaft surface-mounted components facilitating passive data acquisitionby the sensor provide a circumferential radial offset of the cathetertip with respect to the vessel wall.

Distally-Housed Embodiments

In these embodiments, radial distance from the vessel wall and/or axialalignment is achieved by radially expanding members mounted to aninternally-based actuation tube that is actuated from the proximalhandle via methods well-known to those skilled in the art of catheteractuation. Once the radially expanding member is no longer needed, itmay be retracted into the distal catheter shaft.

The embodiments shown in FIGS. 18A, 26, 27 and 28, previously described,show embodiments of the catheter-based and flow-directed vascular accessdevices, however these same embodiments can be used for the passivesensor-directed embodiments as well. The same expanding members mayfacilitate radial expansion and axial alignment for passive dataacquisition.

As previously described, relocating the fluid ports just proximal of thedistal ‘house’ conserves precious catheter ‘real estate’: the distalsection is reserved for a bulky flow-directable member, while theslimmer actuation member follows the fluid lumens back to the proximalhandle.

2.3.1.3 Sensor-Directed, Active

In the active sensor-directed embodiments of the catheter-based vascularaccess devices, placement of the device is facilitated by data receivedfrom the sensor(s) located on the catheter shaft during catheteradvancement by actively manipulating the catheter shaft and subsequentlythe catheter tip. User interaction is required to advance the catheteraccording to the data received and displayed by the sensor(s), and thesensor(s) are again used to verify catheter tip placement at the desiredtarget site. User interaction is also required to optimize the sensor(s)information received in these embodiments as this function cannot beaccomplished by virtue of the catheter design alone.

The distal catheter design may be modified to accomplish activeacquisition of sensor data, or data acquisition that utilizes userinteraction to facilitate either its basic acquisition or optimization.The distal catheter design may facilitate placement of the sensor aminimum distance, when measured radially, from the vessel wall to insurethat enough flow, as well as steady flow is experienced in the areadirectly adjacent to the sensor (as described in section 2.3.1). Thedistal catheter design may facilitate axial alignment of the ultrasoundsensor with respect to the flow of blood adjacent to it (as described insection 2.3.2). Further, the distal catheter design may facilitateradial distance and axial alignment on demand, by the user.

2.3.1.3.1 Shaft Surface-Mounted, Balloon Embodiments

In these embodiments, radial distance from the vessel wall and/or axialalignment is achieved by a balloon member mounted onto the cathetershaft. The balloon is inflated from a proximally-located port bytechniques well-known to those skilled in the art of balloon catheters.

FIGS. 22A, 22B and 22C, previously described, depict embodiments inwhich the distal catheter shaft is deflected and the sensor is movedaway from the vessel wall. This movement may not only optimize the datathe ultrasound sensor is to acquire, but facilitate the very acquisitionof that data in the first place. Furthermore, to facilitate sensor axisalignment to the blood flow once tip actuation has taken place, thesensor can be mounted in an off-axis or skewed manner. The angulardifference depends on the amount of catheter bend created by ballooninflation, and this can be pre-determined. FIG. 22A shows theun-inflated non-skewed transducer mounted embodiment, and likely theresulting beam profile. FIG. 22B shows the inflated state of the deviceand the resultant improved transducer position away from the vesselwall; however an unimproved beam profile may still remain. FIG. 22Cshows the inflated state of the device couple with an off-axis mountedtransducer that provides for a more optimum beam profile.

FIG. 21, previously described, shows at least 2 ‘staggered’ balloonsthat facilitate flow around the catheter shaft, however were just oneballoon placed and further inflated, it could provide a means by whichthe user could actively reposition the catheter with respect to thevessel wall as needed during catheter advancement and subsequentplacement at the target site.

2.3.1.3.2 Shaft Surface-Mounted, Non-Balloon Embodiments

In these embodiments, radial distance from the vessel wall and/or axialalignment is achieved by radially expanding members mounted onto thecatheter shaft surface and actuated from the proximal handle via severalmethods well-known to those skilled in the art of catheter actuation,i.e.: push/pull tube or wire, outer diameter sheath, etc.

FIGS. 23, 24 and 25, previously described, show embodiments ofcatheter-based and sensor-directed vascular access devices in whichshaft surface-mounted components facilitate passive data acquisition bythe sensor by providing a circumferential radial offset of the cathetertip with respect to the vessel wall. However, were these membersasymmetrical with respect to the radial direction, they may alsofacilitate the ability to manually offset the distal tip from a proximalactuation thereby creating active direction to the sensor.

2.3.1.3.3 Distally-Housed Embodiments

In these embodiments, radial distance from the vessel wall and/or axialalignment is achieved by radially expanding members mounted to aninternally-based actuation tube that is actuated from the proximalhandle via methods well-known to those skilled in the art of catheteractuation. Once the radially expanding member is no longer needed, itmay be retracted into the distal catheter shaft.

FIGS. 18A, 26, 27 and 28, previously described, show embodiments ofcatheter-based and flow-directed vascular access devices in whichdistally-housed components facilitate passive data acquisition by thesensor by providing a circumferential radial offset of the catheter tipwith respect to the vessel wall. However, were these membersasymmetrical with respect to the radial direction, they may alsofacilitate the ability to manually offset the distal tip from a proximalactuation, thereby creating active direction to the sensor.

As previously described, relocating the fluid ports just proximal of thedistal ‘house’ conserves precious catheter ‘real estate’: the distalsection is reserved for a bulky flow-directable member, while theslimmer actuation member follows the fluid lumens back to the proximalhandle.

2.3.1.3.4 Steerable Embodiments

In these embodiments, radial distance from the vessel wall is achievedby a steerable distal catheter section actuatable from the proximalhandle by techniques well-known to those skilled in the art of steerablecatheters, i.e.: a distally-mounted pull-wire. Once tip deflection is nolonger needed, it may be relaxed into a straight position. It is to beappreciated that steering techniques may be used to provide desiredtransducer orientation within the vessel.

FIGS. 34A and 34B show a catheter-based vascular access device in whichthe proximal section is made of a relatively stiffer material whencompared to the distal section to facilitate the columnar strengthrequired during distal steering actuation. FIGS. 34A and 34B includecatheter shaft 500, proximal section 594, pull wire 596, distal section592 and beam profile 590. The pull-wire 596 would be affixed to thedistal section 592, either proximal or distal to the sensor. The sensorcould be mounted off-center with respect to the catheter shaft 500, anywhere from about 0 degrees to about 180 degrees, depending upon theangle created by the pull-wire 596, as shown in FIG. 34A, or the sensorcould remain axially-oriented while the pull-wire 596 is affixed to thedistal catheter shaft 500 in a axially-aligned position, as shown inFIG. 34B. Alternatively, the sensor could be positioned such that itfaces a backward direction as well.

2.3.2 Stylet-Based

Stylet-based devices allow the catheter to have characteristics itnormally wouldn't have without the stylet, i.e.: stiffness or shape.Moreover, the stylet affords that catheter the additional benefit ofhaving these characteristics at certain times, only when needed.

An additional benefit of the stylet-based device is that a fluid lumenmay be utilized for passage of the stylet since the stylet will beremoved once the catheter has been appropriately placed. Since a lumenwould not need to be dedicated to sensor(s) or other functionality,precious ‘real estate’ of an approximately 5 F or smaller catheter isoptimized. The stylet embodiments in the following sections can be usedboth with fluid lumens that exit out the distal tip or out through sideslots.

Embodiments of the inventive device include two basic forms. Someembodiments of the stylet-based vascular access device are passivelydirected by the sensor(s) during stylet/catheter advancement through thevasculature. Other embodiments require active manipulation of thestylet/catheter tip to acquire and or optimize the data collected by thesensor(s).

2.3.2.1 Sensor-Directed, Passive

In the passive sensor-directed embodiments of the stylet-based vascularaccess devices, placement of the device is facilitated by data receivedpassively from the sensor(s) located on either the catheter or styletshaft during catheter advancement. User interaction is required toadvance the catheter according to the data received and displayed by thesensor(s), and the sensor(s) are again used to verify catheter tipplacement at the desired target site. However, no user interaction isrequired to optimize the sensor(s) information received in theseembodiments: this function is passively accomplished by virtue of thestylet/catheter design.

The stylet design may be modified to accomplish passive acquisition ofsensor data, or data acquisition that does not require user interactionto facilitate either its basic acquisition or optimization. The styletmay facilitate placement of the sensor a minimum distance, when measuredradially, from the vessel wall to insure that enough flow, as well assteady flow is experienced in the area directly adjacent to the sensor(as described in section 2.3.1). The stylet may also facilitate axialalignment of the ultrasound sensor with respect to the flow of bloodadjacent to it (as described in section 2.3.2).

FIGS. 35A and 35B show an embodiment of a sensor-directed vascularaccess device in which a mostly circular pre-formed stylet is advancedthrough a catheter lumen to create a passive mechanism by whichtransducer position is maintained so that data can be acquired. This isachieved via the stylet's 600 exit out a distally-placed port, eitherout the side of the catheter shaft 500 or directly out the tip. FIGS.35A and 35B include catheter shaft 500, transducer 502 and stylet 600.FIG. 35A shows a single loop, similar to a ‘halo’ in shape exiting aside port and FIG. 35B shows multiple loops, similar to a ‘pig-tail’,also exiting out a side port. Like a pig-tail, the loops diameters canget smaller, remain the same, or get larger as one moves distally on thestylet body.

FIGS. 36A and 36B show another embodiment utilizing a pre-formed styletto shape the catheter shaft itself without exiting a side port. In thisembodiment, the catheter would have to accommodate a separate lumen forstylet delivery. FIG. 36A illustrates the pre-formed stylet prior toentering the distal section. FIG. 36B shows the shaped distal sectionwith the stylet in place. FIGS. 36A and 36B include catheter shaft 500,proximal section 604, distal section 606, preformed stylet 602,transducer 502, beam profile 612 and vessel wall 510.

2.3.2.2 Sensor-Directed, Active

In the active sensor-directed embodiments of the stylet-based vascularaccess devices, placement of the device is facilitated by data receivedfrom the sensor(s) located on the catheter shaft or stylet tip duringcatheter advancement by actively manipulating the catheter shaft andsubsequently the catheter tip. User interaction is required to advancethe catheter according to the data received and displayed by thesensor(s), and the sensor(s) are again used to verify catheter tipplacement at the desired target site. User interaction is also requiredto optimize the sensor(s) information received in these embodiments asthis function cannot be accomplished by virtue of the catheter designalone.

Coupled with a torque-able main/proximal catheter shaft 500, any of theFIG. 40 designs may be utilized for actively placing the sensor-directedcatheter into the vessel, centrally with respect to blood flow.

2.3.3 Guidewire-Based Devices

Guidewire-based devices may be used independently of the catheter it isdesigned to work with; it may be used with other catheters, assuming thesizing needs, i.e.: the inner diameter of the catheter lumenaccommodates the largest outer diameter of the guidewire, are met.

Embodiments of the guidewire-based inventive device include three basicforms. Some embodiments have tips directed mostly by fluid flow withinthe vasculature. Other embodiments are passively directed by thesensor(s) during guidewire/catheter advancement through the vasculature.Other embodiments require active manipulation of the guidewire/cathetertip to acquire and or optimize the data collected by the sensor(s).

2.3.3.1 Flow-Directed

As previously described in both the catheter and stylet-based devices,in the flow-directed embodiments of guidewire-based vascular accessdevices, placement of the device is ‘automatic’ in that minimal userinteraction is required to position the catheter at the target site. Theguidewire, and subsequently the catheter itself, is positioned‘automatically’ by utilizing the blood flowing adjacent to and aroundit. The sensor is therefore used to verify guidewire/catheter tipplacement at the desired target site as opposed to providing informationduring advancement to facilitate the advancement itself.

In these embodiments, blood flow is again utilized by flow-directablemembers mounted directly onto the guidewire. The guidewire is advancedinto the vasculature, the flow-directable component is actuated, and theguidewire is allowed to ‘float’ to the desired target site. Once thetarget site is believed to have been reached, the user can verifyposition with the sensor(s). Then when the guidewire is no longerrequired, it can be removed leaving only the catheter shaft (with fluiddelivery capability).

2.3.3.1.1 Guidewire-Mounted Sensor, Over the Wire

As described previously in Section 2.2, the catheter, once placed, maybe able to deliver at least 2 different fluids through at least 2dedicated lumens simultaneously. Further, the guidewire should be ableto enter the vasculature alone and first, and then be completelyremoved. In an “over-the-wire” configuration, the guidewire may furtherbe able to be removed entirely within the catheter shaft.

FIG. 37 shows an embodiment of an over-the-wire guidewire-based devicein which the sensor(s) is also mounted on the guidewire 622. FIG. 37includes distal catheter shaft 614, fluid 616, guidewire 622, balloon620 and transducer 502. In this embodiment, the guidewire 622 would beadvanced into the vasculature, the balloon 620 would be inflated, theguidewire 622 would ‘float’ to the target site, the position would beverified with the attached sensor(s), the catheter (with fluid lumens)would be advanced to the target site, the balloon would be deflated, andthe guidewire would be pulled out of the catheter.

Although this embodiment specifically illustrates a balloon-basedflow-directed member, other such members as previously described thatcan collapse small enough to run through an internal catheter lumencould also be utilized.

2.3.3.1.2 Catheter-Mounted Sensor, Over the Wire

FIG. 38A shows an embodiment of an over-the-wire guidewire-based devicein which the sensor(s) is mounted on the catheter. FIG. 38A includesdistal catheter shaft 614, fluid 616, distal catheter tip 618, guidewire622, balloon 620 and transducer 502. FIG. 38B shows an example of apossible cross-sectional configuration of the distal catheter shaft(right-side of Figure) vs. the very distal catheter tip (left side ofFigure). FIG. 38B includes distal catheter tip 630, distal cathetershaft 632, fluid lumens 636, guidewire lumens 634 and transducer niche638. In this embodiment, the wire would be advanced into thevasculature, the balloon would be inflated, the guidewire would ‘float’to the apparent target site, the catheter (with fluid lumens andsensor(s)) would be advanced to the apparent target site, the positionwould be verified with the attached sensor(s), the balloon would bedeflated, and the guidewire would be pulled out of the catheter.

Although this embodiment specifically illustrates a balloon-basedflow-directed member, other such members as previously described thatcan collapse small enough to run through an internal catheter lumencould also be utilized.

2.3.3.1.3 Guidewire-Mounted Sensor, Rapid Exchange

FIG. 39 shows an embodiment of a rapid exchange guidewire-based devicein which the sensor(s) is again mounted on the guidewire 646, howeverthe guidewire would not reside completely within the entire cathetershaft 632 as in the over-the-wire devices; instead, the guidewire 646could reside only within a small lumen located at the distal cathetertip. FIG. 39 includes distal catheter shaft 632, fluid 644, guidewire646, collapsed balloon 640, rapid exchange section 642 and transducer502. This may allow larger fluid delivery lumens since a lumen dedicatedfor the guidewire need not travel the entire catheter length. In thisembodiment, the wire 646 would be advanced into the vasculature, theballoon would be inflated, the guidewire 646 would ‘float’ to the targetsite, the position would be verified with the attached sensor(s), thecatheter (with fluid lumens) would be advanced to the target site, theballoon would be deflated, and the guidewire 646 would be pulled out ofthe catheter.

Although this embodiment specifically illustrates a balloon-basedflow-directed member, other such members as previously described thatcan collapse small enough to run through a rapid exchange lumen couldalso be utilized.

2.3.3.1.4 Catheter-Mounted Sensor, Rapid Exchange

FIG. 40 shows an embodiment of a rapid exchange guidewire-based device,as previously described, in which the sensor(s) is again mounted on thecatheter. FIG. 40 includes distal catheter shaft 632, fluid 644,guidewire 646, collapsed balloon 640, rapid exchange section 642 andtransducer 502. This may allow larger fluid delivery lumens since alumen dedicated for the guidewire 646 need not travel the entirecatheter length. In this embodiment, the wire 646 would be advanced intothe vasculature, the balloon would be inflated, the guidewire would‘float’ to the apparent target site, the catheter (with fluid lumens andsensor) would be advanced to the apparent target site, the positionwould be verified with the attached sensor(s), the balloon would bedeflated, and the guidewire would be pulled out of the catheter.

Alternatively, the distal catheter shaft where the rapid exchange lumenis located in FIG. 40 could be split in a longitudinal fashion so as tofacilitate removal of the guidewire without needing the entire balloonassembly to retract through the rapid exchange lumen.

FIG. 41 shows another embodiment of FIG. 40 in which one of the distalfluid lumen ports could have a section that is split in a longitudinalfashion as opposed to being completely open. FIG. 41 includes distalcatheter shaft 632, fluid 644, guidewire 646, collapsed balloon 640,separation 650 and transducer 502. The distal guidewire 646 is retractedthrough the distal section of the split port until the separator 650feature reaches the split section. The separator 650 then spreads andseparates the entire port length such that the entire guidewire 646 isfreed from the lumen and can be removed separately from the cathetershaft 632.

Although these embodiments specifically illustrate balloon-basedflow-directed members, other such members as previously described thatcan collapse small enough to run through a rapid exchange lumen couldalso be utilized.

2.3.3.2 Sensor-Directed (Passive)

In the passive sensor-directed embodiments of the guidewire-basedvascular access devices, placement of the device is facilitated by datareceived passively from the sensor(s) located on the guidewire orcatheter shaft during catheter advancement. User interaction is requiredto advance the catheter according to the data received and displayed bythe sensor(s), and the sensor(s) are again used to verify catheter tipplacement at the desired target site. However, no user interaction isrequired to optimize the sensor(s) information received in theseembodiments: this function is passively accomplished by virtue of theguidewire/catheter design.

Any of the embodiments described in FIGS. 37, 38A, 38B, 39, 40 and 41may be utilized to facilitate a passive sensor-directed catheterpositioning technique.

2.3.3.3 Sensor-Directed (Active)

In the active sensor-directed embodiments of the catheter-based vascularaccess devices, placement of the device is facilitated by data receivedfrom the sensor(s) located on the catheter shaft during catheteradvancement by actively manipulating the catheter shaft and subsequentlythe catheter tip. User interaction may be needed to advance the catheteraccording to the data received and displayed by the sensor(s), and thesensor(s) are again used to verify catheter tip placement at the desiredtarget site. User interaction may be utilized to optimize the sensor(s)information received in these embodiments.

FIG. 42 shows an embodiment of a sensor-directed guide-wire based deviceadvanced to the target site via active manipulation of the guidewire 646during advancement by the user. FIG. 42 includes guidewire 646, vesselwall 510, inflated balloon 652 and transducer 502. Assuming a torquableguidewire shaft is available, a radially-asymmetric balloon could bemounted on the distal guidewire end. Once inflated, the guidewire 646could be actively ‘steered’ through the vasculature by using the off-setcreated by the balloon 652. The left side of the figure shows anuninflated balloon; the right side shows an inflated balloon 652.

Many of the previously described embodiments may also be utilized tofacilitate an active sensor-directed catheter positioning technique.

3.0 Device for Securement of Proximal End of Access Device

Once the vascular access device has been placed and its distal tipposition confirmed, a means by which to secure the proximal cathetershaft is needed. This proximal securement device may hold the catheterhub in place and prevent migration with respect to the skin incision,and may manage the connections, whether electrical, fluid oractuation/inflation in nature.

A securement device is affixed to the patient's skin at a suitablelocation near the puncture site using a suitable biocompatible pressuresensitive adhesive. The securement device has a mounting surface adaptedto engage with the device hub described herein. The device hub may beaffixed to the mounting surface using any suitable mechanicalattachment, e.g. snaps, friction lock or keyed surfaces. The device huband/or the securement device may include suitable RFID tags as describedin section 7.0.

Various details of the design for a securement device may be appreciatedthrough reference to U.S. Pat. Nos. 7,153,291 and 7,223,256,incorporated herein by reference in their entirety.

FIG. 43 shows an embodiment of a securement device that attaches to theproximal catheter shaft 500 thereby minimizing catheter tip migrationfrom the target site. FIG. 43 includes pad 660, receiver 662, cathetershaft 500, hub 666 and skin incision 664 as well as connections such asfluid 670, electrical 674 and actuator 672. To facilitate ease of use,connections may remain on the catheter hub 666 itself, i.e., as‘pigtails’, such as: electrical 674 (to make the transducer and ECGconnections), fluid 670 (to a luer fitting to facilitateinflation/deflation and fluid delivery), or mechanical 672 (tofacilitate some sort of distal component actuation or manipulation).

FIGS. 44A and 44B show top and end views, respectively, of analternative embodiment of a securement device. FIG. 44A includes pad660, receiver 662, catheter shaft 500, catheter hub 666, fasteners 676,docketing station 678 and skin incision 664 as well as connections suchas fluid 670, electrical 674 and actuation 672. FIG. 44B includesadhesive epad 680, docket station 678, pad 660 and connections such asfluid 670, electrical 674 and actuation 672. In this embodiment, a smartcatheter hub 666 is positioned on the proximal end of the vascularaccess device. The smart hub 666 is designed such that the placement ofthe hub 666 into the receiver would facilitate the necessaryconnections, i.e.: transducer, electrical activity, fluid delivery . . .etc. This could be accomplished by any number of methods, for example,the hub could be snapped in place, held with Velcro or engaged with akeyed mechanism. The smart catheter hub 666 includes all of theconnections for the added functionalities used in the vascular accessdevice. Once connected, the smart catheter hub 666 establishes theappropriate conductivity between the vascular access device and theguiding system. In the illustrated embodiment, the smart hub makes 666connections for two electrical 674, two fluid 670 and one actuation 672interfaces.

4.0 Device and Method for Improving Workflow Efficiency of BedsidePatient Care

An aspect of the invention describes RFID and or barcode based labelingand identification of devices and players in the bedside care workflow.The invention also describes a method for making use of such devices forworkflow optimization. In particular the invention relates to using twoor more focused energy transmitters and receivers in order to detecteach others presence in each others field of view.

Other aspects of the following embodiments share some or all of thefollowing characteristics:

The use of RFID concepts and RFID based devices (tags, readers,synchronization and optimization) in medical care workflow.

Tagging devices using RFID, barcodes or other suitable machine readableindicators as well as using such tags for players in the medical careworkflow. Players include any of a variety of heath care providers thatinteract with the patient and/or the device, are responsible fordispensing the device or ensuring the device is or remains properlyplaced during use.

Optimize medical workflow by maintaining and integrating records ofdevices and activities, by programming activities on a “just-in-time”basis as needed and as resources are available.

These and other aspects of the various embodiments of the invention willbe appreciated in the description that follows.

The VasoNova PICC system may provide for workflow tracking, which isimportant for optimizing operational efficiency. More PICCs can beplaced in a given time period by identifying and avoiding significantdown time. To help in analyzing workflow and time management during thePICC placement and confirmation process, the VasoNova PICC systemenables tracking by recording the time at various key steps during theprocess.

A simple but comprehensive tracking system is setup with three key timeentries and various work types that are identified and entered into thesystem by the operator.

In one embodiment, the three key time entries are:

-   -   Receive consult request    -   Start ‘work’ on case    -   Stop ‘work’ on case

Non-limiting examples of primary work types are:

-   -   Gather patient data (check history, allergies, labs, etc.)    -   Transportation to case (cart/supplies) and patient consent    -   Sterile setup    -   Venipuncture    -   Catheter insertion/placement    -   Verification of tip position    -   Secure catheter    -   Order/wait for x-ray    -   Confirm catheter ready for use

Other work types can be added as desired and work types can be combined.For example sterile setup, venipuncture, catheter insertion,verification, and securing catheter may be grouped together as a singlework type called ‘procedure’.

Data entry for tracking can be done by means of pressing buttons locatedon a small mobile device that is to be worn as one carries a pedometeror digital pager. The device interfaces with the VasoNova handheld unitand it may be connected to the handheld by a cord or it may have awireless connection. Alternatively, scanning bar codes orelectromagnetic strips for example could accomplish the data entry.

In the case of a data entry device with buttons, specific tasks aretracked by pushing a ‘start’ button followed by ‘task’ button that ishighlighted by using ‘up’ and ‘down’ buttons that are easily located onthe device by their position and confirmed on the GUI of the handheld.Once the task is completed, the ‘stop’ button is pushed, which thenrecords the stop time for that task, which is simultaneously recorded asthe start time for the next task in the process as illustrated in FIG.45.

The VasoNova handheld GUI has a menu feature that indicates whichworkflow interval is being tracked and the operator can modify or changethe present task by using the ‘up’ and ‘down’ buttons on the data entrydevice as shown in FIG. 46. FIG. 46 includes handheld GUI 690, startbutton 692, stop button 694, up button 696, enter button 698 and downbutton 700.

The buttons have different shapes and sizes that are easily memorized bythe operator so that they can be located and pressed through a sterilegown if the device is clipped to the operator's belt for example

The GUI will display the tasks and with the present task highlighted asillustrated in FIG. 47. The task can be changed at any time by pressingthe up/down buttons on the data entry device.

FIG. 48 shows the players in a medical workflow. According to anembodiment of the invention, users e.g., hospital medical personnel orplayers wear RFID tags or other machine detectable labels. FIG. 48includes users 106 a and 106 b, devices 108 a, 108 b, 108 c and 108 d,database 122, RFID reader 132 a and 132 b, workflow processor 136 andsensor processor 138. Players may have their ID integrated provided as aseparate article of may be integrated into an existing article used bythe player, e.g., on their pager, phone, PDA, nametag, and the like.Devices (S) have RFID tags or barcodes on packaging labels. Patientshave RFID tags associated with them and on their documents. A SensorProcessor is integrated with the VasoNova Guiding System (e.g., RFID tagreader). An individual Workflow Processor 136 is integrated with theVasoNova Guiding System. A centralized Optimization Processor isresiding on the server and makes use of the hospital database. RFID tagscan be placed on other pieces of equipment or with other players of thebedside care system: radiologists, X-ray systems, etc. The VasoNova RFIDreader 132 a/132 b, the Sensor Processor 138 and the Workflow Processor136 integrated in the VasoNova Guiding System allow for coordination ofall players and for workflow optimization.

While RFID tags are used in the above description, the invention is notlimited only to the use of RFID tags but may include the use of anysuitable machine readable or detectable device that may be configuredfor use in tracking the progress of a medical procedure.

The U.S. Pat. No. 5,311,871 entitled “Smart Needle” by Paul Yock is alsoincorporated by reference.

U.S. Pat. No. 6,860,422 “Method and Apparatus for Tracking Documents ina Workflow” by -Hull et al. is also incorporated herein by reference inits entirety.

Further, the following patents and published application areincorporated herein by reference in their entirety:

U.S. Pat. No. 5,546,949

U.S. Pat. No. 4,706,681

U.S. Pat. No. 5,515,853

U.S. Pat. No. 5,830,145

U.S. Pat. No. 6,259,941

U.S. Pat. No. 6,298,261

U.S. Pat. No. 6,958,677

U.S. Pat. No. 7,054,228

U.S. Published Patent Application 20030036696.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1. A transcutaneous ultrasound vascular access guiding systemcomprising: an elongate body having a handle; a guide on the elongatebody configured to receive a vascular access device; a single elementultrasound device on the elongate body configured to provide A-Modeimaging, Doppler and correlation-based blood velocity estimation; aprocessor to process and correlate ultrasound information from thesingle element ultrasound device; and a system for information outputbased on the output of the processor.
 2. The device of claim 1 furthercomprising: a lens positioned to control the single element ultrasoundbeam shape.
 3. The device of claim 1 further comprising a lenspositioned on the ultrasound device configured to provide a matchinglayer between the ultrasound transducer and the skin.
 4. The device ofclaim 1 constructed as a single-use device.
 5. The device of claim 1wherein the information output is a scrolling chart.
 6. The device ofclaim 1 wherein the Doppler information can be bidirectional.
 7. Thedevice of claim 1 wherein the Doppler acquisition can be pulsed wave orcontinuous wave.
 8. The device of claim 1 wherein the guide attached tothe imaging device is configured to guide one of the endovascular deviceselected from the group consisting of: a needle; a stylet; a catheter;and an introducer.
 9. The device of claim 8 further comprising: anadaptor to match the outer diameter of the endovascular guided device tothe inner diameter of the guide.
 10. The device of claim 8 wherein theendovascular device is configured to slide or move with respect to theimaging device as to provide single hand deployment capability of theendovascular guided device.
 11. A method of accessing a blood vesselcomprising the steps of: preparing sterile vascular access site onpatient's skin; sliding a vascular access device in the device guide,flush aligning with the tip of the imaging element, and locking inposition; positioning the assembly on the patient's skin on the sterilesite without the use of ultrasound gel; orienting the assembly like aflashlight until the desired vessel can be seen on the scrolling chartdisplay; advancing the endovascular element into the vasculature bysliding the guide element over the imaging device; and monitoring theadvancement of the endovascular device towards the desired target byusing at least one element from a list including A-mode imaging, Dopplerflow information, and correlation-based blood flow information.
 12. Anendovascular device comprising: an elongate body; an element on or inthe elongate body configured to generate, emit or produce sound waves;and a device to control the generation, emission or production of soundwaves from the element.
 13. The device of claim 12 wherein the elementis placed on or in the elongate body.
 14. The device of claim 12 whereinthe device to control operates by pushing and pulling wires manually.15. The device of claim 12 wherein the device to control is actuated bymotorized movement of moving connective parts.
 16. The device of claim12 wherein the device to control generation of the element is actuatedby delivering a gas through a lumen on or in the elongate body.
 17. Thedevice of claim 12 wherein the sound generating elements may be actuatedby delivering fluid through a lumen of the endovascular device.
 18. Thedevice of claim 12 wherein the sound generating elements may be actuatedthrough interaction with the blood or an anatomical site.
 19. The deviceof claim 12 wherein sound waves are generated by rubbing notched orserrated components.
 20. The device of claim 12 wherein sound waves maybe generated by hitting a stylet against a solid member in order togenerate a repetitive ping.
 21. The device of claim 12 wherein soundwaves may be generated by a moving membrane.
 22. The device of claim 12wherein sound waves may be generated by a moving membrane configured toamplify sound.
 23. The device of claim 12 wherein a device lumen isconfigured to amplify sound.
 24. An auscultation system comprising: oneor more sound sensitive elements; a sound processor in communicationwith the one or more sound sensitive elements; and an information outputdevice in communication with the sound processor.
 25. The system ofclaim 24 wherein the sound processor is configured such that a pluralityof auscultation devices can be synchronized to provide acoustictriangulation for accurate detection of an endovascular sound source.26. A guiding method for endovascular devices comprising the steps of:positioning one or more sound sensitive elements on a patient's chest;inserting a sound emitting endovascular device into the patient'svasculature; emitting sounds from the endovascular device; and detectingthe sounds from the emitting step with the sound sensitive elements. 27.The method of claim 26 wherein the emitting step is performedcontinuously, intermittently or on demand.
 28. The method of claim 26wherein the sound intensity measured in the detecting step is used toestimate the distance between the sound emitting endovascular device andthe one or more sound sensitive elements.
 29. The method of claim 26further comprising: triangulating the sounds from the detecting step tolocate the sound emitting endovascular device with respect to the one ormore sound sensitive elements.
 30. A method to locate an endovasculardevice comprising an ultrasound sensor using one or more transcutaneousultrasound systems, comprising the steps of: introducing an endovascularmember containing an ultrasound sensor into the vasculature of a body;sending and receiving ultrasound waves in the vasculature using theultrasound sensor; placing one or more transcutaneous ultrasound systemson the patient's body; detecting the interference between theendovascular ultrasound device and the transcutaneous ultrasound systemsusing either the endovascular sensor or with any of the transcutaneoussystems; and notifying the user when interference has been detected suchthe user becomes aware of the presence of the endovascular device in thefield of view of the transcutaneous systems.
 31. The method of claim 30wherein the endovascular device is configured to emit ultrasoundsignals.
 32. The method of claim 30 wherein the endovascular device isconfigured to receive ultrasound signals.
 33. The method of claim 30wherein the transcutaneous ultrasound system is configured to emitultrasound signals.
 34. The method of claim 30 wherein thetranscutaneous ultrasound system is configured to receive ultrasoundsignals.
 35. The method of claim 30 wherein the transcutaneousultrasound system is configured as an ultrasound imaging scan headconnecting to an ultrasound imaging system.
 36. The method of claim 30wherein the information in the detecting step from severaltranscutaneous ultrasound systems is used for triangulating and/orlocating the endovascular ultrasound sensor.
 37. The method of claim 30wherein the endovascular ultrasound device is connected to the one ormore transcutaneous system such as to allow synchronization oftransmitting and receiving ultrasound waves in the same region of thebody.
 38. An endovascular device, comprising: an elongate body sized forinsertion into the vasculature; a sensor on the distal end of theelongate body; and a structure on or in the elongate body to move itstip from an inner blood vessel wall while maintaining the blood streamflow when the endovascular device is in a blood vessel.
 39. The deviceof claim 38, the elongate body further comprising: a distal segment thatis flexible and made of metal or polymer, and the polymer may bereinforced to increase tensile strength.
 40. The device of claim 38wherein the structure is a star shaped balloon on or about the elongatebody.
 41. The device of claim 38 wherein the structure is a 2 piecedisplaced asymmetrical shaped balloon.
 42. The device of claim 38wherein the structure is a deployable circular braid.
 43. The device ofclaim 38 wherein the structure is a deployable balloon.
 44. The deviceof claim 38 wherein the structure comprises: strips cut in the elongatebody material; and deployed to move the endovascular device from a wallusing a deployment member.
 45. The device of claim 38 wherein thestructure comprises a deployable basket.
 46. An endovascular device,comprising: an elongate body sized for insertion into the vasculature; asensor on the distal end of the elongate body; and a structureconfigured to align the elongate body tip or the sensor with the bloodstream while maintaining the blood stream flow.
 47. The endovasculardevice of claim 46 wherein the structure comprises axial alignmentfacilitated by a tether component attached to the elongate body.
 48. Thedevice of claim 46 wherein the alignment with the blood stream isprovided by a star shaped balloon.
 49. The device of claim 46 whereinthe structure for alignment with the blood stream is provided by a 2piece displaced asymmetrical shaped balloon.
 50. The device of claim 46wherein the structure for the alignment with the blood stream isprovided by a deployable circular braid.
 51. The device of claim 46wherein the structure for the alignment with the blood stream isprovided by a deployable balloon.
 52. The device of claim 46 wherein thestructure for the alignment with the blood stream is provided by stripscut in the elongate body material and deployed using a deploymentmember.
 53. The device of claim 46 wherein the structure for thealignment with the blood stream is provided by a deployable basket. 54.A securement device for an endovascular member which provides electricaland optical sensor connectors and actuation elements to connect andcontrol sensors and devices attached at the distal end of theendovascular members.
 55. A system for tracking clinical procedures andworkflow, comprising: a workflow processor; an input interface; anoutput interface; a code reader; a communication component; and adatabase interface.
 56. The system of claim 55 wherein the workflowprocessor stores information about procedure times, device information,patient and operator information, calculates parameters of the procedurelike time duration and elapsed time between activities, and providesstatistical data analysis of such parameters.
 57. The system of claim 55wherein information about the endovascular procedure is input into thesystem through a dedicated user interface guiding data acquisition. 58.The system of claim 55 wherein the output interface presents results ofprocedure workflow analysis.
 59. The system of claim 55 wherein the codereader can be an RFID reader, a bar code reader or a reader of anycomputer readable label.
 60. The system of claim 55 wherein thecommunication component can communicate over a wired network or awireless network with a hospital information system.
 61. The system ofclaim 55 wherein the communication component can communicate with othersystems for tracking clinical procedures and establish a network of suchsystems.
 62. The system of claim 55 wherein the database interfaceallows the procedure and workflow information to be archived.
 63. Amethod for tracking clinical procedures and workflow, comprising:entering a time when a consult request is received; entering a time whena work step is started; and entering a time when a work step isfinished.
 64. The method of claim 63 where the work step comprises thefollowing activities: gathering patient data; transporting to a case;obtaining patient consent; gaining vascular access; placing anendovascular device or any other type of device; providing therapythrough the endovascular device; removing or securing an endovasculardevice; ordering or waiting for x-ray or other confirmatory imagingmodality; repositioning a device based on input from an imagingmodality; and documenting that an endovascular device is ready for use.